Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Split-septum needleless valve-connector FDA UDI
- Device Name
- UserGard(R) Needle-Free Injection Hub FDA UDI
- Model / Reference
- IPN035959 FDA UDI
- Description
- UserGard(R) Needle-Free Injection Hub FDA UDI
Identifiers
- Catalog Number
- UH-14703 FDA UDI
- Primary DI / UDI-DI
- 00801902003652 FDA UDI
- 510(k) Number
- K923653 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Split-septum needleless valve-connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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: Split-septum needleless valve-connector
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System — HUMMINGBIRD MED DEVICES INC · Class I
- Umbilical Catheter with Integral Low-Volume Closed Blood Sampling System — HUMMINGBIRD MED DEVICES INC · Class II
Cleared under the same submission
K923653 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
- Teleflex Incorporated
Sources (1)
- FDA UDI db7fb05e-fa9b-4ae9-9c14-73fdf4b828b0 36 fields · synced Jun 1, 2026