Who else makes this device?

Name: Drainage Bag
Brand: Drainage Bag

Drainage Bag · Bag, Bile Collecting → Gastroenterology & Urology

1manufacturer

1catalogue number

1510(k) clearance

3recalls on this code

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 Drainage Bag
Listed by	Remington Medical, Inc., United States
FDA product code	EXF
Device type	Bag, Bile Collecting
Device class	Class 2
Regulation	21 CFR 876.5010
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Shipping carton of 20, shipping carton of 25
Sizes	Total volume 600 ml

Catalogue Numbers

Catalogue numbers for Drainage Bag
Catalogue number	Size	Status
600-D	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
Navarre	Bard Access Systems, Inc.	1
VacuBag	Bard Access Systems, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K990428	1999-08-12

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Drainage Bag
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Remington Medical, Inc.	UDI-DI	2023-11-03	Class II	Labeling mix-ups	There is an error with the “Use by Date” and “Date of Manufacturer” on the box label.	3080 devices

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2011-01-12	Not classified	Other	There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.	89294 units	2011-09-13
2007-07-23	Not classified	Process control	Sterility, inadequate — Pathway may not be sterile as labeled.	45,000 units	2009-04-06

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.

Drainage Bag