Identity
- Trade Name
- Bolink(TM) FDA UDI
- Generic Name
- Enteral feeding kit, adult/paediatric, non-sterile FDA UDI
- Device Name
- Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector FDA UDI
- Model / Reference
- 1085 FDA UDI
- Description
- Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector FDA UDI
Identifiers
- Catalog Number
- 1085 FDA UDI
- Primary DI / UDI-DI
- 00867622000401 FDA UDI
- 510(k) Number
- K170555 FDA UDI
- FDA Product Code
- PIF FDA UDI
- GMDN Term
- Enteral feeding kit, adult/paediatric, non-sterile 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Enteral feeding kit, adult/paediatric, non-sterile
Bolink(TM) by U Deliver Medical L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Enteral feeding kit, adult/paediatric, non-sterile.
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Cleared under the same submission
K170555 also covers:
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
- U Deliver Medical L.l.c.
Sources (1)
- FDA UDI 101feabe-07fd-4450-be32-5331f3555058 36 fields · synced May 30, 2026