Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Anaesthesia conduction catheter FDA UDI
- Device Name
- Epidural Catheterization Kit with FlexTip Plus(R), Open Tip Single-Port Catheter and Needle Disposal Feature FDA UDI
- Model / Reference
- IPN045607 FDA UDI
- Description
- Epidural Catheterization Kit with FlexTip Plus(R), Open Tip Single-Port Catheter and Needle Disposal Feature FDA UDI
Identifiers
- Catalog Number
- AK-05502 FDA UDI
- Primary DI / UDI-DI
- 00801902005137 FDA UDI
- 510(k) Number
- K103658 FDA UDI
- FDA Product Code
- CAZ FDA UDI
- GMDN Term
- Anaesthesia conduction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5140 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
No
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 90 Centimeter FDA UDI
Category: Anaesthesia conduction catheter
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia conduction catheter.
- EPINAUT — IMEDICOM CO., LTD. · Class II
- EPINAUT — IMEDICOM CO., LTD. · Class II
- Temena — Te ME NA Sas · Class II
- Uni-Flo — Summit Medical Products, Inc. · Class II
- GRAFTSITE — Summit Medical, LLC · Class II
- Uni-Flo — Summit Medical Products, Inc. · Class II
- EPINAUT — IMEDICOM CO., LTD. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Cleared under the same submission
K103658 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 52906037-78a5-42fc-9ad8-94ee4fbf16ba 37 fields · synced May 30, 2026