Identity
- Trade Name
- BIONIX DEVELOPMENT CORPORATION FDA UDI
- Generic Name
- Enteral feeding/decompression tube clearing stem FDA UDI
- Model / Reference
- GF-09510 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10859911004914 FDA UDI
- 510(k) Number
- K180605 FDA UDI
- FDA Product Code
- KNT FDA UDIPIF FDA UDI
- GMDN Term
- Enteral feeding/decompression tube clearing stem FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bionix Development Corporation by Bionix, LLC — Class II — FDA UDI — listed in FDA GUDID — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI 1bf45f84-e1fc-4ad4-b032-53142ddbc5c2 34 fields · synced Jun 8, 2026