Identity
- Trade Name
- Bynex FDA UDI
- Generic Name
- Intestinal ostomy bag/support kit FDA UDI
- Device Name
- One-piece Ostomy bag Flat 10 pieces/box 20 boxes/carton FDA UDI
- Model / Reference
- 12071V FDA UDI
- Description
- One-piece Ostomy bag Flat 10 pieces/box 20 boxes/carton FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948909401297 FDA UDI
- FDA Product Code
- PQE FDA UDI
- GMDN Term
- Intestinal ostomy bag/support kit 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
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: Intestinal ostomy bag/support kit
Bynex by Shaoxing Haoshide Medical Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intestinal ostomy bag/support kit.
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- MDK-MEDICAL — Henan Maidingkang Medical Technology Co., Ltd. · Class I
- Hollister — Hollister Incorporated · Class I
- New Image — Hollister Incorporated · Class I
- New Image — Hollister Incorporated · Class I
- New Image — 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 |
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Manufacturer
- Manufacturer
- Shaoxing Haoshide Medical Products Co., Ltd.
Sources (1)
- FDA UDI f37d8d68-87a5-40ab-ab56-f9c661748527 33 fields · synced May 29, 2026