AccessGUDID - DEVICE: Plasmaflo (04537693005365)

GUDID

Device Identifier (DI) Information

Brand Name: Plasmaflo
Version or Model: OP-05W(A)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ASAHIKASEI MEDICAL MT K.K.

Primary DI Number: 04537693005365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 692097404 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36194	Apheresis system filter, whole blood	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDP	Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ee01d68-f06a-4ee5-b02a-554d50793406
Public Version Date: December 14, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2014