Identity
- Trade Name
- Assura FDA UDI
- Generic Name
- Colostomy irrigation kit, reusable FDA UDI
- Device Name
- Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Sleeves FDA UDI
- Model / Reference
- 12830 FDA UDI
- Description
- Assura Irrigation Set. 1 Water bag, 1 Irrigation cone, 1 Belt plate, 2 Irrigation Sleeves FDA UDI
Identifiers
- Catalog Number
- 12830 FDA UDI
- Primary DI / UDI-DI
- 05708932651448 FDA UDI
- FDA Product Code
- EXD FDA UDI
- GMDN Term
- Colostomy irrigation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colostomy irrigation kit, reusable
Assura by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colostomy irrigation kit, reusable.
- Coloplast — Coloplast A/S · Class II
- SenSura Mio — Coloplast A/S · Class II
- Coloplast — Coloplast A/S · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 00140d77-16e9-4926-9179-9fab19458a98 36 fields · synced May 31, 2026