FDA.reportPublic FDA data

BD Vacutainer® Serum Seperator (SST) Blood Collection Tubes

Primary DI
30382903679905
Brand
BD Vacutainer® Serum Seperator (SST) Blood Collection Tubes
Company
BECTON, DICKINSON AND COMPANY
Model
367990
Catalog number
367990
Device description
TUBE SST PLC 16X125 10.0 PLBLCE RD/GR
Published
2024-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K230855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230855000BD Vacutainer® Serum Separator (SST™) Blood Collection TubesBecton, Dickinson and Company2023-12-20JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903679909PackageGS110In Commercial Distribution
30382903679905PrimaryGS10
00382903679904Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290367990950382903679909
3038290367990530382903679905
00382903679904003829036799043829036799040382903679904

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulantA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. 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 lead, toxicology, nutritional-chemistry, and other plasma chemistry determinations). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
001292192
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

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