FDA.reportPublic FDA data

BD Vacutainer® PST™ Gel and Lithium Heparin 64 USP Units

Primary DI
50382903688246
Brand
BD Vacutainer® PST™ Gel and Lithium Heparin 64 USP Units
Company
BECTON, DICKINSON AND COMPANY
Model
368824
Catalog number
368824
Device description
BD Vacutainer® PST™ Gel and Lithium Heparin 64 USP Units
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945952000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945952000VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEBd Becton Dickinson Vacutainer Systems Preanalytic1995-01-18JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903688246PrimaryGS10
00382903688241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290368824650382903688246
00382903688241003829036882413829036882410382903688241

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, clot activator/gel separatorA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator and a gel to separate serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
1000
Lot or batch
true
Expiration date on label
true

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