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Coloplast

FDA UDI

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Coloplast FDA UDI
Generic Name
One-piece intestinal ostomy bag, open-ended FDA UDI
Device Name
Coloplast Fistula Bed Drainage Bag. Bed drainage bag. FDA UDI
Model / Reference
14010 FDA UDI
Description
Coloplast Fistula Bed Drainage Bag. Bed drainage bag. FDA UDI

Identifiers

Catalog Number
14010 FDA UDI
Primary DI / UDI-DI
00762123051078 FDA UDI
FDA Product Code
FON FDA UDI
GMDN Term
One-piece intestinal ostomy bag, open-ended FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: One-piece intestinal ostomy bag, open-ended

Coloplast by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as One-piece intestinal ostomy bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 916face7-b68b-4895-92e8-365ba46c8b98 35 fields · synced Jun 6, 2026