Barkey plasmatherm V

Basic Information

• Brand Name: Barkey plasmatherm V
• Primary DI: 04059201001701
• Version / Model: US-V
• Catalog Number: 00003296
• Company Name: Barkey GmbH & Co. KG
• Labeler DUNS: 312555782
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-12
• Public Version: 1
• Public Version Date: 2021-11-22
• Public Version Status: New
• Public Device Record Key: 3ce51166-3a84-4219-bd70-0210b72217bb

Device Description

Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZL	Device, Warming. Blood And Plasma	Hematology	864.9205	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43434	Cryopreserved blood/tissue thawing unit	An electrically-powered device intended to be used to thaw, in a controlled manner, frozen units of whole blood, blood components (e.g., blood cells, plasma), and/or other biological tissues contained in storage cryobags. The device is typically programmable and can use a number of heating methods to achieve thawing (e.g., dry heat, microwave oven, water bath); it may provide agitation and be able to detect when thawing has been completed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04059201001701	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK100063	0

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius