Identity
- Trade Name
- BD Vacutainer® 9NC 0.109M 2.7 mL FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, anticoagulant FDA UDI
- Device Name
- TUBE CIT PLH 13X75 2.7 BLBL CE L/BL .109 FDA UDI
- Model / Reference
- 363095 FDA UDI
- Description
- TUBE CIT PLH 13X75 2.7 BLBL CE L/BL .109 FDA UDI
Identifiers
- Catalog Number
- 363095 FDA UDI
- Primary DI / UDI-DI
- 50382903630955 FDA UDI
- 510(k) Number
- K013971 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, anticoagulant FDA UDI
- Models / Variants
- BD Vacutainer® FDA UDI9NC 0.109M 2.7 mL 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, anticoagulant
BD Vacutainer® +1 more model by Becton, Dickinson U.K. Limited — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated blood collection tube IVD, anticoagulant.
- BD Vacutainer® Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Sodium HeparinN (NH) 158 U.S.P. Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
K013971 also covers:
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes — BECTON DICKINSON AND COMPANY
- BD Vacutainer® Buffered Sodium Citrate 0.3mL - 0.109M — Becton, Dickinson U.K. Limited
- BD Vacutainer® Plus Citrate Tube — Becton, Dickinson U.K. Limited
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 U.K. Limited
Sources (1)
- FDA UDI 982d69e2-ff19-4d07-88d4-05460729be71 36 fields · synced Jun 6, 2026