Identity
- Trade Name
- Coloplast FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, open-ended FDA UDI
- Device Name
- Coloplast Fistula and Wound Management System / Coloplast . without filter. 1 Fistula and Wound Manager Maxi. 1 Fistula Flexible Lid Maxi without filter. 1 Tracing guide. 1 Transparent cover sheet. 1 Fistula Drain Port. 1 Clamp. 1 Pump per retail box. Maxi. Fistula and Wound Manager Size Maxi. FDA UDI
- Model / Reference
- 14070 FDA UDI
- Description
- Coloplast Fistula and Wound Management System / Coloplast . without filter. 1 Fistula and Wound Manager Maxi. 1 Fistula Flexible Lid Maxi without filter. 1 Tracing guide. 1 Transparent cover sheet. 1 Fistula Drain Port. 1 Clamp. 1 Pump per retail box. Maxi. Fistula and Wound Manager Size Maxi. FDA UDI
Identifiers
- Catalog Number
- 14070 FDA UDI
- Primary DI / UDI-DI
- 05708932702676 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
MR Safe 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.
- ESTEEM+ — CONVATEC, PURCHASING DEPARTMENT · Class I
- ESTEEM — CONVATEC, PURCHASING DEPARTMENT · Class I
- ACTIVELIFE — CONVATEC, PURCHASING DEPARTMENT · Class I
- ESTEEM+ — CONVATEC, PURCHASING DEPARTMENT · Class I
- ESTEEM+ — CONVATEC, PURCHASING DEPARTMENT · Class I
- Premier — Hollister Incorporated · Class I
- Premier — Hollister Incorporated · Class I
- Premier — Hollister Incorporated · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI ac0db6c6-3143-484b-aeb1-45b03bc80235 37 fields · synced May 30, 2026