Identity
- Trade Name
- CAREFLOW(TM) 1 LUMEN 3FR X 200MM FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Kits Contents : Catheter 3FR OD 1.1mmx200mm; J guidewire OD 0.46mmx450mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Floswitch(TM) Overneedle Introducer 20G OD 1.0mmx45mm, Dilator 4FR OD 1.27mm ID 0.51mm & Floswitch(TM). FDA UDI
- Model / Reference
- 681644 FDA UDI
- Description
- Kits Contents : Catheter 3FR OD 1.1mmx200mm; J guidewire OD 0.46mmx450mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Floswitch(TM) Overneedle Introducer 20G OD 1.0mmx45mm, Dilator 4FR OD 1.27mm ID 0.51mm & Floswitch(TM). FDA UDI
Identifiers
- Catalog Number
- 681644 FDA UDI
- Primary DI / UDI-DI
- 00886333616442 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) 1 Lumen 3fr X 200mm 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 64f117f3-cf93-40ba-ac11-bf17c8b93304 36 fields · synced May 30, 2026