Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- PICC Two-Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter FDA UDI
- Model / Reference
- IPN914867 FDA UDI
- Description
- PICC Two-Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip(R) Catheter FDA UDI
Identifiers
- Catalog Number
- PS-01672 FDA UDI
- Primary DI / UDI-DI
- 10801902158427 FDA UDI
- 510(k) Number
- K042126 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
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Peripherally-inserted central venous catheter
At ARROW, we provide a reliable and efficient PICC Two-Lumen Peripherally Inserted Central Catheter Set for long-term intravascular access. With its thin, flexible design and dedicated accessories, this device enables safe and effective administration of medications, nutrients, and fluids.
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
K042126 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 afc26d27-4776-4c49-abbd-acc2ecb32351 36 fields · synced Jun 28, 2026