Plasmaflo

Basic Information

• Brand Name: Plasmaflo
• Primary DI: 04537693005365
• Version / Model: OP-05W(A)
• Company Name: ASAHIKASEI MEDICAL MT K.K.
• Labeler DUNS: 692097404
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 4
• Public Version Date: 2020-12-14
• Public Version Status: Update
• Public Device Record Key: 5ee01d68-f06a-4ee5-b02a-554d50793406

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDP	Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04537693005365	GS1
Package	24537693005369	GS1	carton (inner)	3	In Commercial Distribution
Package	14537693005362	GS1	carton (outer)	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit