Identity
- Trade Name
- BD Vacutainer® SST™ FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, clot activator/separator FDA UDI
- Device Name
- BD Vacutainer® SST™ FDA UDI
- Model / Reference
- 368015 FDA UDI
- Description
- BD Vacutainer® SST™ FDA UDI
Identifiers
- Catalog Number
- 368015 FDA UDI
- Primary DI / UDI-DI
- 30382903680154 FDA UDI
- 510(k) Number
- K230855 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, clot activator/separator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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: Evacuated blood collection tube IVD, clot activator/separator
BD Vacutainer® SST™ by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated blood collection tube IVD, clot activator/separator.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
Cleared under the same submission
BK050036 also covers:
- BD Vacutainer® K2 EDTA (K2E) 10.8 mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA (K2E) 18 mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA (K2E) Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA 10.8 mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA 3.6 mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA 5.4 mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® K2 EDTA 7.2 mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
K230855 also covers:
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Serum Seperator (SST) Blood Collection Tubes — BECTON DICKINSON AND COMPANY
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI dc6e02d1-7cc5-4656-b1f3-2d9cd12c74d7 36 fields · synced May 30, 2026