FDA.reportPublic FDA data

BD Vacutainer® PST™ Gel and Lithium HeparinN 126 Units

Primary DI
30382903679646
Brand
BD Vacutainer® PST™ Gel and Lithium HeparinN 126 Units
Company
BECTON, DICKINSON AND COMPANY
Model
367964
Catalog number
367964
Device description
TUBE PST PLC 16X100 8.0 PLBL GN/GR
Published
2016-07-28
Public version status
Update
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
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
50382903679640PackageGS110In Commercial Distribution
30382903679646PrimaryGS10
00382903679645Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290367964050382903679640
3038290367964630382903679646
00382903679645003829036796453829036796450382903679645

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulant/separatorA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], and a separator (e.g., gel) to separate blood plasma 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., testing plasma in molecular diagnostics and viral load detection). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume8Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00This way up
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
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30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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