Identity
- Trade Name
- BD Vacutainer® FX 5mg 4mg Blood Collection Tubes FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, anticoagulant/antiglycolytic FDA UDI
- Device Name
- TUBE GLU PLH 13X75 2.0 BLBLCE GR FDA UDI
- Model / Reference
- 368920 FDA UDI
- Description
- TUBE GLU PLH 13X75 2.0 BLBLCE GR FDA UDI
Identifiers
- Catalog Number
- 368920 FDA UDI
- Primary DI / UDI-DI
- 30382903689201 FDA UDI
- 510(k) Number
- K901449 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, anticoagulant/antiglycolytic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- Not 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
BD Vacutainer® FX 5mg 4mg Blood Collection Tubes by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K901449 also covers:
- BD Vacutainer® FX 10mg 8mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Lithium HeparinN (LH) 75 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Lithium HeparinN (LH) 78 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Lithium HeparinN Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Sodium Fluoride 30mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Sodium Fluoride/Potassium Oxalate 10mg/8mg — 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 |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 29eae7c6-8580-4927-bc6b-1311ce7c2958 37 fields · synced Jun 8, 2026