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BD Vacutainer Rapid Serum Tube Plus Blood Collection Tube, Model 368771

by Becton, Dickinson and Company (BD)

510(k) K091292Ref 362782, 368381, 366645, 360069, 360085

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091292↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290HKLZPXSTJQ Basic UDI-DI Date8 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number038290HKLZPXSTJQ Basic UDI-DI Date8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30382903683810 UDI-DI Date28 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK091292 Date25 Aug 2009ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Vacutainer EUDAMED
BD Vacutainer® Trace Element K2 EDTA (K2E) 10.8mg Blood Collection Tubes GUDID
Generic Name
Evacuated blood collection tube IVD, anticoagulant
Device Name
BD Vacutainer® CPT™ Cell Preparation Tube
BD Vacutainer® Trace Element Blood Collection Tube
BD Vacutainer® ACD Blood Collection Tube
BD Vacutainer® Fluoride Blood Collection Tubes
Model / Ref / Catalog
368381, 362782, 366645, 360069, 360085
Primary DI / UDI-DI
30382903683810, 30382903627821, 30382903666455, 00382903600694, 00382903600854
Basic UDI-DI
038290HKLZPXSTJQ, 038290NMIQJQVZHA, 038290GGDRSSUP9T, 038290NWWJFZVQRU
Unit of Use DI
00382903627820, 00382903683819, 00382903666454
510(k) Number
FDA Product Code
JKA
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
GMDN Term
Evacuated blood collection tube IVD, anticoagulant
Device Class
Class A EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 862.1675
EU market of registration
Belgium
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
510(k) NumberEUDAMED
—
510(k)
K091292
GUDID
K213953
Device ClassEUDAMED
Class A
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD Vacutainer Rapid Serum Tube Plus is a blood collection tube designed for serum separation. It is a device used for collecting blood samples and separating serum for laboratory testing.

This tube is supplied as a single-use device and is not for reuse. It is sterile and intended for in vitro diagnostic use. The device is authorized under FDA 510K, IVDR, and MDR regulations.

Other devices from Becton, Dickinson and Company (BD)

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BD Vacutainer Rapid Serum Tube Plus used for?

    The BD Vacutainer Rapid Serum Tube Plus is designed for collecting blood samples and separating serum for laboratory testing. It is intended for in vitro diagnostic use.

  • Is the BD Vacutainer Rapid Serum Tube Plus a single-use device?

    Yes, the BD Vacutainer Rapid Serum Tube Plus is supplied as a single-use device and is not intended for reuse.

  • What regulatory authorizations does the BD Vacutainer Rapid Serum Tube Plus have?

    The BD Vacutainer Rapid Serum Tube Plus is authorized under FDA 510K, IVDR, and MDR regulations.

  • Is the BD Vacutainer Rapid Serum Tube Plus sterile?

    Yes, the BD Vacutainer Rapid Serum Tube Plus is supplied as a sterile device for laboratory use.

Properties

  • Sterile
  • Single Use
  • Animal Tissues
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No