Identity
- Trade Name
- SenSura Mio Flex; Assura AC FDA UDI
- Generic Name
- Intestinal ostomy base plate, flat FDA UDI
- Model / Reference
- 13627 FDA UDI
Identifiers
- Catalog Number
- 13627 FDA UDI
- Primary DI / UDI-DI
- 05708932131186 FDA UDI
- FDA Product Code
- EXB FDA UDI
- GMDN Term
- Intestinal ostomy base plate, flat FDA UDI
- Models / Variants
- SenSura Mio Flex FDA UDIAssura AC FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 50 Millimeter FDA UDITotal Volume — 475 Milliliter FDA UDI
SenSura Mio Flex +1 more model by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 2549b44c-6683-4cc3-889c-cefbf7b79704 36 fields · synced Jun 1, 2026