FDA.reportPublic FDA data

BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate

Primary DI
30382903627609
Brand
BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate
Company
BECTON, DICKINSON AND COMPANY
Model
362760
Catalog number
362760
Device description
TUBE CPTCIT GC 13X100 4.0 MLBL BL/BLK
Published
2016-08-22
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
JCFLYMPHOCYTE SEPARATION MEDIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCFLymphocyte Separation MediumHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903627603PackageGS11In Commercial Distribution
30382903627609PrimaryGS10
00382903627608Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290362760350382903627603
3038290362760930382903627609
00382903627608003829036276083829036276080382903627608

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulant/separator/density solutionA 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], a separator (e.g., gel or elastomer) to separate plasma from bloods cells, and density solution to isolate plasma and mononuclear cells from other whole blood components. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., mononuclear cell analysis, plasma chemistry determinations). Additional blood freezing tubes (cryovials) may be supplied with the device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001292192
Device count
60
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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00885403523451HemoSphere AltaALTASR1ALTASR12026-08-06
00885403523475HemoSphere AltaALTACR1ALTACR12026-08-06
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24

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