FDA.reportPublic FDA data

BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Heparin

Primary DI
30382903627531
Brand
BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Heparin
Company
BECTON, DICKINSON AND COMPANY
Model
362753
Catalog number
362753
Device description
TUBE CPTHEP GC 16X125 8.0 MLBL RD/GN
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
50382903627535PackageGS11In Commercial Distribution
30382903627531PrimaryGS10
00382903627530Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290362753550382903627535
3038290362753130382903627531
00382903627530003829036275303829036275300382903627530

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
Manufacturing date on label
true
Expiration date on label
true

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00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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