Navarre

Bard Navarre Universal Gravity Drainage Bag

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code EXF
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71

Record

Regulatory record for Navarre
Listed by Bard Access Systems, Inc., United States
FDA product code EXF
Device type Bag, Bile Collecting
Device class Class 2
Regulation 21 CFR 876.5010
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published 2015-11-20
Record revised 2024-10-08 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Case of 10
Sizes Total volume 600 ml

Catalogue Numbers

Catalogue numbers for Navarre
Catalogue number Size Status
NDB600 Total Volume 600 ml In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Merit Drainage Depot™ Merit Medical Systems, Inc. 4
Drainage Bag Uresil, LLC 2
Drainage Bag Argon Medical Devices, Inc. 2
Gravity Drainage Bag Uresil, LLC 2
Optimus Gravity Drainage Bag Uresil, LLC 2
Biliary Drainage Kit Marlen Manufacturing And Development Co. 1
VacuBag Bard Access Systems, Inc. 1
Drainage Bag Remington Medical, Inc. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer