Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Peripheral vascular catheter FDA UDI
- Device Name
- Peripherally Inserted Midline Catheter Kit with Sharps Safety Features FDA UDI
- Model / Reference
- IPN034194 FDA UDI
- Description
- Peripherally Inserted Midline Catheter Kit with Sharps Safety Features FDA UDI
Identifiers
- Catalog Number
- ASK-02041-SEH1 FDA UDI
- Primary DI / UDI-DI
- 00801902063571 FDA UDI
- 510(k) Number
- K963257 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Peripheral vascular 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
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
No
FDA UDI
Category: Peripheral vascular catheter
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular catheter.
- Arterial Line Kit — Argon Medical Devices, Inc. · Class I
- DELTAVEN — DELTA MED SPA · Class II
- EXEL Safelet Catheter — Exel International · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- DELTAVEN — DELTA MED SPA · Class II
- EXEL Safelet Catheter — Exel International · Class II
- POWERWAND — ICU MEDICAL, INC. · Class II
- POWERWAND — Access Scientific, Inc. · 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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI b9503d54-46a1-48dc-ad62-6c1adbfd2ccd 37 fields · synced May 29, 2026