plasmatherm 212.10046

GUDID 04059201000001

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

Barkey GmbH & Co. KG

Plasma thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit

• Primary Device ID: 04059201000001
• NIH Device Record Key: ee273696-ba0e-4853-a48c-b8a5c8306956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: plasmatherm
• Version Model Number: US
• Catalog Number: 212.10046
• Company DUNS: 312555782
• Company Name: Barkey GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +12017081400
• Email: info@genesisbps.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com
• Phone: +18662275393
• Email: info@barkey-us.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059201000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK100063

FDA Product Code

• KZL: Device, Warming. Blood And Plasma

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-13

On-Brand Devices [plasmatherm]

• 04059201000018: Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
• 04059201000001: Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution