I'm looking for listing of manufacturers in the US that
includes contact information (e.g. phone, address, email, etc.)?

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Request for Question Clarification by scriptor-ga on 10 Jun 2004 10:52 PDT

Dear mfgmedical,

Since no free comprehensive directories of medical device
manufacturers exist, I assume that you are willing to pay for
purchasing or getting access to a such directory?

Regards,
Scriptor

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Clarification of Question by mfgmedical-ga on 10 Jun 2004 10:55 PDT

Hi Scriptor,

Are we 100% confident there is no free directory out there? 

Best regards,
mfgmedical

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Request for Question Clarification by bobbie7-ga on 10 Jun 2004 12:56 PDT

Dear mfgmedical,

I can provide you with a free searchable database of establishments
engaged in the manufacture, preparation, propagation, compounding,
assembly, or processing of medical devices intended for human use and
commercial distribution. Foreign establishments that export to the U.S
are also registered in this database. This database is updated once a
month.

You must search by Establishment Name to obtain contact information.

For example, I searched for Medtronic and obtained 51 results.

Here are a few of the results.

Establishment: 
MEDTRONIC MINIMED
18000 Devonshire St. 
Northridge,  CA 91325-1219 
Registration Number: 2032227 
Operations:  Manufacturer, Rebuilder/Refurbisher, Specification Developer 
Status: Active 
Date of Registration Status: 2004 

Owner/Operator: 
MEDTRONIC MINIMED
18000 Devonshire St. 
Northridge, CA 91325-1219 
Owner/Operator Number: 
2025512 

Official Correspondent: 
Mr. Mark Faillace
MEDTRONIC MINIMED
18000 Devonshire St. 
Northridge, CA 91325-1219 
Phone: 818-576-5616

---------------------------------------------------------------

Establishment: 
MEDTRONIC BLOOD MANAGEMENT
18501 east plaza dr. 
parker,  CO 80134-9061 
Registration Number: 1718389 
Operations:  Manufacturer 
Status: Active 
Date of Registration Status: 2004 

Owner/Operator: 
MEDTRONIC, INC.
710 Medtronic pkwy., n.e. 
Minneapolis, MN 55432-5604 
Owner/Operator Number: 
2112641 

Official Correspondent: 
ms. Preeti Jain
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr. 
Minneapolis, MN 55428 
Phone: 763-391-9533 1953

---------------------------------------------------------------

MEDTRONIC, INC.
35-37a cherry hill dr. 
Danvers,  MA 01923 
Registration Number: 1220452 
Operations:  Manufacturer, Certifying Agent, Domestic Distributor,
Specification Developer
Status: Active 
Date of Registration Status: 2004 

Owner/Operator: 
MEDTRONIC, INC.
710 medtronic pkwy., n.e. 
Minneapolis, MN 55432-5604 
Owner/Operator Number: 
2112641 

Official Correspondent: 
Mr. Fred Boucher, r.a.c.
MEDTRONIC, INC.
37a cherry hill dr. 
Danvers, MA 01923 
Phone: 978-777-0042 

---------------------------------------------------------------

ARIZONA DEVICE MANUFACTURING
2350 west Medtronic way 
Tempe,  AZ 85281 
Registration Number: 2032545 
Operations:  Manufacturer, Repackager/Relabeller 
Status: Active 
Date of Registration Status: 2004 

Owner/Operator: 
MEDTRONIC, INC.
710 Medtronic pkwy., n.e. 
Minneapolis, MN 55432-5604 
Owner/Operator Number: 
2112641 

Official Correspondent: 
Mr. Tim Samsel
MEDTRONIC, INC.
7000 central Ave. ne 
Minneapolis, MN 55432-3576 
Phone: 763-514-3149 

---------------------------------------------------------------

Would a link to this free database be an adequate answer to your question?


If not, I have also located a Medical Device Companies mailing list
for sale. The approximate cost is of 10 cents per record. They have a
listing of over 17,000 medical device manufacturers. With shipping and
handling this list would cost $1,810.00.

Please let me know how to proceed.

Thanks,
Bobbie7

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Clarification of Question by mfgmedical-ga on 10 Jun 2004 14:01 PDT

Hi Bobby7,

We have the mailing list pretty well under control. Can you provide a
little more detail regarding the db. For example, what type of db, how
does it get updated, and the final cost of it?

Thanks,
mfgmedical

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Request for Question Clarification by bobbie7-ga on 10 Jun 2004 14:25 PDT

Hi mfgmedical!

This is a government online searchable database that you may use for
free.  You can?t download the database. You have to search by the name
of the establishment to obtain the contact information

This is a database of FDA registered establishments engaged in the
manufacture, preparation, propagation, compounding, assembly, or
processing of medical devices intended for human use and commercial
distribution.

How does it get updated, and the final cost of it?

There is no cost to use this database. The database is updated monthly. 




Another government database that might interest you a free online
searchable Device Listing Database.

This database contains a listing of medical devices in commercial
distribution by both domestic and foreign manufacturers.
You may search by device name or owner/operator name.

For example, I searched for ?thermometer? and obtained 143 records.


Here is an example of one of the results:


Proprietary Device Name: BD MERCURY THERMOMETER 
Common/Generic Device Name: MERCURY THERMOMETER 
Classification Name: THERMOMETER, CLINICAL MERCURY 
Device Class: 2 
Product Code: FLK 
Regulation Number: 880.2920 
Medical Specialty: General Hospital 
Owner/Operator: BECTON, DICKINSON & CO.  
Owner/Operator Number: 9922032 
Registered Establishment Name: BD MEDICAL-DIABETES CARE  
Establishment Registration Number: 1035046 
Date of Listing: 12/01/00 
Listing Status: Active  
Establishment Operations: Repackager/Relabeller 

The Registered Establishment Name: BD MEDICAL-DIABETES CARE is
clickable. This takes you to another page where contact information
for the company is provided.

Establishment: 
BD MEDICAL-DIABETES CARE
199 keowee business pkwy. 
Seneca,  SC 29678 
Registration Number: 1035046 
Operations:  Repackager/Relabeller, Initial Distributor, Manufacturer 
Status: Active 
Date of Registration Status: 2005 

Owner/Operator: 
BECTON, DICKINSON & CO.
1 Becton dr. 
Franklin lakes, NJ 07417-1880 
Owner/Operator Number: 
9922032 

Official Correspondent: 
John Schalago
BD MEDICAL-DIABETES CARE
1 Becton drive 
Franklin lakes, NJ 07417-1880 
Phone: 201-847-5663
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm


Thanks, Bobbie7

Hi mfgmedical!


Thanks to the help of my fellow researcher pafalafa-ga, I can provide
you with the free FDA downloadable database of Medical Device
Establishments.

?Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
requires that all establishments engaged in the manufacture,
preparation, propagation, compounding, assembly, or processing of
medical devices intended for human use and commercial distribution in
the United States register their establishments with the Food and Drug
Administration (FDA).?
http://www.fda.gov/cdrh/comp/estregls.html

This information consists of three files. The three files are linked
based on the Establishment Registration Number. You can download any
or all of the following zipped files.

File 1 is the one you need.


The Medical Device Establishment Registration Master File contains the
required information submitted by owner/operators of medical device
establishments in accordance with Section 510 of the Federal Food,
Drug and Cosmetic Act.


File 1. Registration ? This file contains detailed information on each
registered establishment: registra.zip
http://www.fda.gov/cdrh/ftparea/cdrh/registra.zip


File 2. Registration Tradename - Other Trading names for registered
establishments: regtrade.zip
http://www.fda.gov/cdrh/ftparea/cdrh/regtrade.zip


File 3. Device Listing - Device listings submitted by registered
establishments: listing.zip
http://www.fda.gov/cdrh/ftparea/cdrh/listing.zip


Information about how to unzip the files:

- Uncompress the file with WinUnzip, PKUnzip, or other utility; 
- Rename file: filename.lis to filename.txt. 
- If the file is to be imported into a database, the end-of-record
marker is the ¶ symbol
- These files are replaced monthly, usually on the 5th of each month.
- A file description for each file is listed at the following link
along with an explanation of some of the codes used in the file.
http://www.fda.gov/cdrh/comp/estregls.html


Search criteria:
Medical Device Manufacturers
FDA Medical devices
Medical Device Manufacturers database


I hope you find this information useful!

Best regards,
Bobbie7

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Clarification of Answer by bobbie7-ga on 10 Jun 2004 15:40 PDT

Here is the link to the Online Searchable Registration Database.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/registration.cfm

Thank you bobbie7! This should work for us.