Identity
- Trade Name
- Safe N Simple FDA UDI
- Generic Name
- Multiple-piece intestinal ostomy bag, open-ended FDA UDI
- Device Name
- 12" Drainable 2-Piece Pouch Beige 70 mm 2 3/4" Flange with Belt Tabs and one curved tail closure FDA UDI
- Model / Reference
- SNS7212234 FDA UDI
- Description
- 12" Drainable 2-Piece Pouch Beige 70 mm 2 3/4" Flange with Belt Tabs and one curved tail closure FDA UDI
Identifiers
- Catalog Number
- SNS7212234 FDA UDI
- Primary DI / UDI-DI
- 00810040132353 FDA UDI
- FDA Product Code
- EZS FDA UDI
- GMDN Term
- Multiple-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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDI
Category: Multiple-piece intestinal ostomy bag, open-ended
Safe N Simple by Safe N Simple Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-piece intestinal ostomy bag, open-ended.
- SenSura Mio Kids — Coloplast A/S · Class I
- SenSura Mio — Coloplast A/S · Class I
- Assura — Coloplast A/S · Class I
- New Image — Hollister Incorporated · Class I
- SenSura Mio — Coloplast A/S · Class I
- Sensura Flex — Coloplast A/S · Class I
- SenSura Click — Coloplast A/S · Class I
- SenSura Mio — Coloplast A/S · 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
- Safe N Simple Llc
Sources (1)
- FDA UDI 98b82af9-4ea4-4347-9076-d2df26b97b4b 36 fields · synced Jun 8, 2026