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BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes

FDA UDI

Class II (US FDA UDI)

by Becton, Dickinson U.K. Limited

Identity

Trade Name
BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes FDA UDI
Generic Name
Evacuated blood collection tube IVD, anticoagulant FDA UDI
Device Name
TUBE EDTA PLH 16X100 10.0 SLBL USA LAV FDA UDI
Model / Reference
366643 FDA UDI
Description
TUBE EDTA PLH 16X100 10.0 SLBL USA LAV FDA UDI

Identifiers

Catalog Number
366643 FDA UDI
Primary DI / UDI-DI
30382903666431 FDA UDI
510(k) Number
K213670 FDA UDI
K231373 FDA UDI
FDA Product Code
GIM FDA UDI
JKA FDA UDI
GMDN Term
Evacuated blood collection tube IVD, anticoagulant 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® K2 EDTA (K2E) Plus Blood Collection Tubes by Becton, Dickinson U.K. Limited — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Evacuated blood collection tube IVD, anticoagulant.

Cleared under the same submission

BK230980 also covers:

K213670 also covers:

K231373 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton, Dickinson U.K. Limited

Sources (1)

  • FDA UDI e3d98245-746b-45e0-a5c2-29eec5a6405f 36 fields · synced Jun 8, 2026