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VanishPoint Blood Collection Set
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 24011
Identity
- Trade Name
- VanishPoint Blood Collection Set EUDAMEDVanishPoint® FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- VanishPoint Blood Collection Set EUDAMED25G x 3/4" w/7" tubing VanishPoint® Blood Collection Set FDA UDI
- Model / Reference
- 24011 EUDAMEDFDA UDI
- Description
- 25G x 3/4" w/7" tubing VanishPoint® Blood Collection Set FDA UDI
Identifiers
- Catalog Number
- 24011 FDA UDI
- Primary DI / UDI-DI
- 00613703240101 EUDAMEDFDA UDI
- Basic UDI-DI
- 0613703BloodCollectionW8 EUDAMED
- FDA Product Code
- JKA FDA UDIFPA FDA UDI
- EMDN Code
- A01010201 BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Blood collection set, invasive FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI880.5440 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 Blood Collection Set by Retractable Technologies, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K122355 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K112512 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0613703BloodCollectionW8 | 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 dc2344cc-62e9-43a6-9b17-a2290c8fa582 61 fields · synced Jun 19, 2026
- FDA UDI 8505538d-d21d-4ade-8e1e-15a3ed438397 35 fields · synced May 30, 2026
- FDA 510(k) K122355 1 fields · synced May 18, 2026