Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Peripheral intravenous catheterization kit, non-sensing FDA UDI
- Device Name
- One-Lumen Midline Kit FDA UDI
- Model / Reference
- IPN038534 FDA UDI
- Description
- One-Lumen Midline Kit FDA UDI
Identifiers
- Catalog Number
- ASK-02041-EPV FDA UDI
- Primary DI / UDI-DI
- 10801902142211 FDA UDI
- 510(k) Number
- K963257 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Peripheral intravenous catheterization kit, non-sensing 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
Yes
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
Yes
FDA UDI
Category: Peripheral intravenous catheterization kit, non-sensing
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral intravenous catheterization kit, non-sensing.
- Argyle — Cardinalhealth · Class II
- V-Cath — Neo Medical Inc. · Class II
- AMSure® IV Start Kit — AMSINO INTERNATIONAL, INC. · Class II
- NeoMagic — Neo Medical Inc. · Class II
- PowerStick — Neo Medical Inc. · Class II
- V-Cath — Neo Medical Inc. · Class II
- V-Cath — Neo Medical Inc. · Class II
- NAR Kit — NORTH AMERICAN RESCUE, LLC. · Class II
Cleared under the same submission
K963257 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI 1f26176e-94c7-423f-bcb1-1fc178e935c6 37 fields · synced May 30, 2026