Identity
- Trade Name
- BD Microtainer® Z (No Additive Tubes) FDA UDI
- Generic Name
- Capillary blood collection tube IVD, no additive FDA UDI
- Device Name
- TUBE MICRO W/MICROGARD PLN RD FDA UDI
- Model / Reference
- 365963 FDA UDI
- Description
- TUBE MICRO W/MICROGARD PLN RD FDA UDI
Identifiers
- Catalog Number
- 365963 FDA UDI
- Primary DI / UDI-DI
- 30382903659631 FDA UDI
- 510(k) Number
- K991702 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, no additive 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: Capillary blood collection tube IVD, no additive
BD Microtainer® Z (No Additive Tubes) by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Capillary blood collection tube IVD, no additive.
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- Globe Scientific — GLOBE SCIENTIFIC, LLC · Class I
Cleared under the same submission
K991702 also covers:
- BD Microtainer® PST™ Tubes with LH (Lithium Heparin) — BECTON DICKINSON AND COMPANY
- BD Microtainer® PST™ Tubes with LH (Lithium Heparin) - Amber — BECTON DICKINSON AND COMPANY
- BD Microtainer® SST™ — BECTON DICKINSON AND COMPANY
- BD Microtainer® SST™ - Amber — BECTON DICKINSON AND COMPANY
- BD Microtainer® Tubes with LH (Lithium Heparin) — 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 8166806f-733b-42a6-a4c0-637b8c25fc30 36 fields · synced May 30, 2026