Plasmaflo

GUDID 04537693005365

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 clinica

ASAHIKASEI MEDICAL MT K.K.

Apheresis system filter, whole blood
Primary Device ID04537693005365
NIH Device Record Key5ee01d68-f06a-4ee5-b02a-554d50793406
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasmaflo
Version Model NumberOP-05W(A)
Company DUNS692097404
Company NameASAHIKASEI MEDICAL MT K.K.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx
Phone800-526-3522
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104537693005365 [Primary]
GS114537693005362 [Package]
Contains: 24537693005369
Package: carton (outer) [2 Units]
In Commercial Distribution
GS124537693005369 [Package]
Package: carton (inner) [3 Units]
In Commercial Distribution

FDA Product Code

MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-30
Device Publish Date2014-09-23

Devices Manufactured by ASAHIKASEI MEDICAL MT K.K.

04537693005365 - Plasmaflo2018-08-30The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinica
04537693005365 - Plasmaflo2018-08-30 The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from th
04537693003897 - REXEED2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
14537693003900 - REXEED2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
14537693003917 - REXEED2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.
14537693003924 - REXEED2018-03-29 Intended for use in hemodialysis for the treatment of patients suffering from acute or chronic renal failure.

Trademark Results [Plasmaflo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLASMAFLO
PLASMAFLO
87066329 5168444 Live/Registered
DESERT LAKE TECHNOLOGIES, LLC
2016-06-09
PLASMAFLO
PLASMAFLO
73198401 1246970 Live/Registered
Asahi Medical Co., Ltd.
1978-12-28

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