Mabis DMI

U-BAG 24HR Sterile Standard Adhesive Pediatric

Registry build 21.09.26
1manufacturer
13catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code FOC
Manufacturer City Province Registered as Device types
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16

Record

Regulatory record for Mabis DMI
Listed by D-M-S Holdings, Inc.
FDA product code FOC
Device type Bag, Urine Collection, Newborn
Device class Class 2
Regulation 21 CFR 876.5250
Premarket notification Exempt
Record published 2016-09-23
Record revised 2023-05-08 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Distribution end date 2023-05-05

Catalogue Numbers

Catalogue numbers for Mabis DMI
Catalogue number Size Status
D 7531 Withdrawn
D 7525 Withdrawn
D 7513 Withdrawn
D 7501 Withdrawn
D 7521 Withdrawn
D 7540 Withdrawn
D 7535 Withdrawn
D 7533 Withdrawn
D 7515 Withdrawn
D 7517 Withdrawn
D 7537 Withdrawn
D 7505 Withdrawn
D 7511 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Zorro-Flow Inc. Zorroflow LLC 2

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