FDA.reportPublic FDA data

BD Vacutainer® K2E (EDTA) 7.2mg

Primary DI
30382903688617
Brand
BD Vacutainer® K2E (EDTA) 7.2mg
Company
Becton, Dickinson U.K. Limited
Model
368861
Catalog number
368861
Device description
BD Vacutainer® K2E (EDTA) 7.2mg
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
BK0500360
BK050036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0500360
BK050036000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903688611PackageGS110In Commercial Distribution
30382903688617PrimaryGS10
00382903688616Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290368861150382903688611
3038290368861730382903688617
00382903688616003829036886163829036886160382903688616

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length75Millimeter
Total Volume4Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
225931062
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903630470BD Vacutainer® Plus Citrate Tube3630473630472016-07-28
30382903630487BD Vacutainer® Plus Citrate Tube3630483630482016-07-28
30382903679530BD Vacutainer® SST™ II Advance3679533679532016-08-22
30382903679554BD Vacutainer® SST™ II Advance3679553679552016-08-22
30382903679578BD Vacutainer® SST™ II Advance3679573679572016-08-22
00382903660162BD Seditainer™ Stand3660163660162024-04-18
30382903684947BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes3684943684942024-04-04
30382903688846BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes3688843688842024-04-04
30382903688860BD Vacutainer® LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes3688863688862024-04-08
30382903666431BD Vacutainer® K2 EDTA (K2E) Plus Blood Collection Tubes3666433666432016-07-28
50382903688864BD Vacutainer® LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes3688863688862024-04-08
30382903685012BD Vacutainer® Z (No Additive) Plus Urine Tube3685013685012024-04-04
50382903684941BD Vacutainer® LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes3684943684942024-04-04
50382903685016BD Vacutainer® Z (No Additive) Plus Urine Tube3685013685012024-04-04
50382903688840BD Vacutainer® LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes3688843688842024-04-04
50382903643788BD A-Line™ Arterial Blood Collection Syringe3643783643782024-04-02
50382903643894BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643893643892024-04-02
50382903643900BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643903643902024-04-02
50382903643917BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643913643912024-04-02
50382903643931BD Preset™ Eclipse™ Arterial Blood Collection Syringe3643933643932024-04-02

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