Identity
- Trade Name
- BIONIX DEVELOPMENT CORPORATION FDA UDI
- Generic Name
- Enteral feeding tube clearing kit FDA UDI
- Device Name
- Sample- DeClogger 20-22 F/Green FDA UDI
- Model / Reference
- SP-20913 FDA UDI
- Description
- Sample- DeClogger 20-22 F/Green FDA UDI
Identifiers
- Catalog Number
- 20913 FDA UDI
- Primary DI / UDI-DI
- 00859911004320 FDA UDI
- 510(k) Number
- K905164 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Enteral feeding tube clearing kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Yes
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
Category: Enteral feeding tube clearing kit
Bionix Development Corporation by Bionix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enteral feeding tube clearing kit.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- CLOG Zapper Enteral Feeding tube Declogging System — Corpak Medsystems · Class II
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
Cleared under the same submission
K905164 also covers:
- BIONIX DEVELOPMENT CORPORATION — Bionix, LLC
- BIONIX DEVELOPMENT CORPORATION — Bionix, LLC
- BIONIX DEVELOPMENT CORPORATION — Bionix, LLC
- BIONIX DEVELOPMENT CORPORATION — Bionix, LLC
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI 0bb7f468-9d7e-451d-a06e-cd051d795423 36 fields · synced Jun 8, 2026