Identity
- Trade Name
- VanishPoint IV Catheter EUDAMEDVanishPoint® FDA UDI
- Generic Name
- Peripheral vascular catheter FDA UDI
- Device Name
- VanishPoint IV Catheter EUDAMED24G x 3/4" VanishPoint® IV Catheter PUR FDA UDI
- Model / Reference
- 31221 EUDAMEDFDA UDI
- Description
- 24G x 3/4" VanishPoint® IV Catheter PUR FDA UDI
Identifiers
- Catalog Number
- 31221 FDA UDI
- Primary DI / UDI-DI
- 00613703312204 EUDAMEDFDA UDI
- Basic UDI-DI
- 0613703IVcatheterRJ EUDAMED
- FDA Product Code
- FOZ FDA UDI
- EMDN Code
- C0101010202 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, W/O INJECTION VALVES EUDAMED
- GMDN Term
- Peripheral vascular catheter FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
VanishPoint IV Catheter by Retractable Technologies, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051355 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K081420 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0613703IVcatheterRJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Retractable Technologies, Inc.
- EUDAMED SRN
- US-MF-000031781
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED dd2f0d8f-bbad-43e4-8a3b-8ad86b0b980f 61 fields · synced Aug 4, 2026
- FDA UDI 242e3c1f-801a-4956-9f26-f6a7c38052ab 35 fields · synced May 30, 2026
- FDA 510(k) K051355 1 fields · synced May 18, 2026