Identity
- Trade Name
- CAREFLOW(TM) 4 LUMEN 8.5FR X 150MM FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Kits Contents : Catheter 8.5FR OD 2.90mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Overneedle Introducer 16G OD 1.7mmx70mm, Dilator 9FR OD 3.0mm ID 0.96mm,Syringe 5ml & Scalpel. FDA UDI
- Model / Reference
- 681731 FDA UDI
- Description
- Kits Contents : Catheter 8.5FR OD 2.90mmx150mm; J guidewire OD 0.9mmx450mm, Secondary Fixation Device, Steel Needle Introducer 17G OD 1.4mmx70mm; Overneedle Introducer 16G OD 1.7mmx70mm, Dilator 9FR OD 3.0mm ID 0.96mm,Syringe 5ml & Scalpel. FDA UDI
Identifiers
- Catalog Number
- 681731 FDA UDI
- Primary DI / UDI-DI
- 00886333617319 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
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
Category: Vascular catheter introduction set, nonimplantable
Careflow(tm) 4 Lumen 8.5fr X 150mm by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Argon Critical Care Systems Singapore Pte. Ltd.
Sources (1)
- FDA UDI 400d230f-aaaa-406a-97a3-19115574adc4 36 fields · synced May 30, 2026