Identity
- Trade Name
- BD MiniDraw™ SST™ Capillary Blood Collection Tube FDA UDI
- Generic Name
- Capillary blood collection tube IVD, K2EDTA FDA UDI
- Device Name
- BD MiniDraw™ SST™ Capillary Blood Collection Tube FDA UDI
- Model / Reference
- 366604 FDA UDI
- Description
- BD MiniDraw™ SST™ Capillary Blood Collection Tube FDA UDI
Identifiers
- Catalog Number
- 366604 FDA UDI
- Primary DI / UDI-DI
- 50382903666046 FDA UDI
- 510(k) Number
- K230391 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, K2EDTA 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
No
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: Capillary blood collection tube IVD, K2EDTA
BD MiniDraw™ SST™ Capillary Blood Collection Tube by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Capillary blood collection tube IVD, K2EDTA.
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
- Minivette® POCT 50µl K3E, US — Sarstedt Aktiengesellschaft & Co.KG · Class I
- HemoScreen — Pixcell Medical Technologies, Ltd. · Class II
- Minivette® POCT 100µl K3E — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Minivette® POCT 100µl K3E — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
Cleared under the same submission
K230391 also covers:
- BD MiniDraw™ Finger Sizing Tool — BECTON DICKINSON AND COMPANY
- BD MiniDraw™ Finger Sleeve, Extra-Large — BECTON DICKINSON AND COMPANY
- BD MiniDraw™ Finger Sleeve, Large — BECTON DICKINSON AND COMPANY
- BD MiniDraw™ Finger Sleeve, Medium — BECTON DICKINSON AND COMPANY
- BD MiniDraw™ Finger Sleeve, Small — 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 698fc299-316e-4463-b5f3-17419108297b 36 fields · synced Jun 8, 2026