Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Haemodialysis/central venous catheterization kit FDA UDI
- Device Name
- Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Sharps Safety Features, and Maximal Barrier Precautions FDA UDI
- Model / Reference
- IPN036187 FDA UDI
- Description
- Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Sharps Safety Features, and Maximal Barrier Precautions FDA UDI
Identifiers
- Catalog Number
- CDC-12123-XP1A FDA UDI
- Primary DI / UDI-DI
- 10801902111774 FDA UDI
- FDA Product Code
- NIE FDA UDI
- GMDN Term
- Haemodialysis/central venous catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 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: Haemodialysis/central venous catheterization kit
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis/central venous catheterization kit.
- VYGON — Vygon Corp. · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
- Disposable Hemodialysis Access Catheter Set — Guangdong Baihe Medical Technology Co., Ltd · Class II
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 35c9854e-ec73-489e-a6f6-61fefada5b35 35 fields · synced Jun 8, 2026