FDA.reportPublic FDA data

BD Vacutainer® PPT™ K2E 15.8 mg

Primary DI
50382903627993
Brand
BD Vacutainer® PPT™ K2E 15.8 mg
Company
BECTON, DICKINSON AND COMPANY
Model
362799
Catalog number
362799
Device description
BD Vacutainer® PPT™ K2E 15.8 mg
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PJEBlood/plasma collection device for DNA testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJEBlood/Plasma Collection Device For Dna TestingClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972075000VACUTAINER BRAND PPT PLASMA PREPARATION TUBEBecton Dickinson Vacutainer Systems1998-02-24PJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903627993PrimaryGS10
00382903627998Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290362799350382903627993
00382903627998003829036279983829036279980382903627998

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K2EDTA/gel separatorA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA) and a gel to separate 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
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
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
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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