Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- Pressure Injectable Three-Lumen PICC pre-loaded with Arrow(R) VPS(R) Stylet FDA UDI
- Model / Reference
- IPN919386 FDA UDI
- Description
- Pressure Injectable Three-Lumen PICC pre-loaded with Arrow(R) VPS(R) Stylet FDA UDI
Identifiers
- Catalog Number
- CDC-35063-VPS FDA UDI
- Primary DI / UDI-DI
- 10801902186765 FDA UDI
- 510(k) Number
- K121941 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Peripherally-inserted central venous catheter 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
Yes
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
Yes
FDA UDI
Category: Peripherally-inserted central venous catheter
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripherally-inserted central venous catheter.
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Synergy — Health Line International Corp · Class II
- PowerPICC — Bard Access Systems, Inc. · Class II
- PowerPICC Provena — Bard Access Systems, Inc. · Class II
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Synergy — Health Line International Corp · Class II
- BioFlo — NAVILYST MEDICAL, INC. · Class II
- Midline Catheter — MEDICAL COMPONENTS INC · Class II
Cleared under the same submission
K121941 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 1702f619-f98f-4d7d-b0dc-4e21a36076a5 37 fields · synced May 30, 2026