Identity
- Trade Name
- CAREFLOW(TM) 1 LUMEN 2.5FR X 60MM FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Kits Contents : Catheter 2.5FR OD 0.9mmx60mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Floswitch(TM) Overneedle Introducer 20G OD1.0mmx45mm, Dilator 4Fr OD1.27mm ID 0.51, Floswitch(TM) FDA UDI
- Model / Reference
- 681615 FDA UDI
- Description
- Kits Contents : Catheter 2.5FR OD 0.9mmx60mm; J guidewire OD 0.46mmx350mm, Steel Needle Introducer 22G OD 0.75mmx40mm; Floswitch(TM) Overneedle Introducer 20G OD1.0mmx45mm, Dilator 4Fr OD1.27mm ID 0.51, Floswitch(TM) FDA UDI
Identifiers
- Catalog Number
- 681615 FDA UDI
- Primary DI / UDI-DI
- 00886333616152 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
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
Category: Vascular catheter introduction set, nonimplantable
Careflow(tm) 1 Lumen 2.5fr X 60mm 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 9b9769fe-5829-4fe9-805f-f2c5c62ab24e 36 fields · synced Jun 1, 2026