FDA.reportPublic FDA data

Plasmaflo

Primary DI
04537693005365
Brand
Plasmaflo
Company
ASAHIKASEI MEDICAL MT K.K.
Model
OP-05W(A)
Device description
The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinical setting.
Published
2014-09-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14537693005362PackageGS12In Commercial Distribution
24537693005369PackageGS13In Commercial Distribution
04537693005365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1453769300536214537693005362
2453769300536924537693005369
04537693005365045376930053654537693005365

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis system filter, whole bloodA sterile device designed to separate plasma from the cellular components of whole blood during manual/automated apheresis (the separation, collection, and reinfusion of blood) for donation of blood products or apheresis therapy. It typically contains a microporous membrane (usually with pores 0.2 to 0.6 micrometers) or a hollow-fibre column; it may also be intended to filter microorganisms and/or particles. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-526-3522xx@xx.xx

Regulatory Flags#

DUNS number
692097404
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04537693003903REXEED18S2015-11-01
04537693003910REXEED21S2015-11-01
04537693003927REXEED25S2015-11-01
04537693003897REXEED15S2015-11-01
14537693003900REXEED18S2015-11-01
14537693003917REXEED21S2015-11-01
14537693003924REXEED25S2015-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800293007784Bone ProfilerMegagen Implant Co. LtdMDP2025-05-09
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00887868199196Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199202Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
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00887868199233Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
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00887868199257Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
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00887868199288Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199295Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199301Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199318Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199325Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199332Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199349Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199356Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199363Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13
00887868199370Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMDP2020-07-13