Identity
- Trade Name
- VanishPoint® FDA UDI
- Generic Name
- Blood collection tube holder, single-use FDA UDI
- Device Name
- VanishPoint® Blood Collection Tube Holder Small Tube Adapter FDA UDI
- Model / Reference
- 22711 FDA UDI
- Description
- VanishPoint® Blood Collection Tube Holder Small Tube Adapter FDA UDI
Identifiers
- Catalog Number
- 22711 FDA UDI
- Primary DI / UDI-DI
- 00613703227119 FDA UDI
- 510(k) Number
- K971763 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Blood collection tube holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Blood collection tube holder, single-use
VanishPoint® by Retractable Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood collection tube holder, single-use.
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- Adapter sleeve — Sarstedt Aktiengesellschaft & Co.KG · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- BCI — ICU MEDICAL, INC. · Class II
- Blood Collection Tube Holders — Dynarex Corp. · Class I
- GCB Medical Supply — GCB MEDICAL LLC · Class II
Cleared under the same submission
K971763 also covers:
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
- Retractable Technologies, Inc.
Sources (1)
- FDA UDI 9aa867b8-f821-443f-b33e-c1441b53740b 36 fields · synced Jun 8, 2026