Barkey GmbH & Co. KG

Address:Gewerbestrasse 8,Leopoldshoehe North Rhine-Westphalia,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Warming. Blood And Plasma (KZL) (5) Warmer, Thermal, Infusion Fluid (LGZ) (1)

Premarket Exempt

Clear

plasmatherm - 04059201000001 Catalog Number : 00000448

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

Device Class : 2

Duns Number: 312555782

Premarket Exempt : No

Product Code : KZL

Prescription Use : Yes

Device Count : 1

plasmatherm - 04059201000018 Catalog Number : 00000460

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

Device Class : 2

Duns Number: 312555782

Premarket Exempt : No

Product Code : KZL

Prescription Use : Yes

Device Count : 1

Barkey plasmatherm V - 04059201001701 Catalog Number : 00003296

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

Device Class : 2

Duns Number: 312555782

Premarket Exempt : No

Product Code : KZL

Prescription Use : Yes

Device Count : 1

Barkey plasmatherm C&G - 04059201001817 Catalog Number : 00003475

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

Device Class : 2

Duns Number: 312555782

Premarket Exempt : No

Product Code : KZL

Prescription Use : Yes

Device Count : 1

Barkey plasmatherm C&G - 04059201002135 Catalog Number : 00010340

Device Description : Thawing and warming device for HPC, blood products, IV solution

Device Class : 2

Duns Number: 312555782

Premarket Exempt : No

Product Code : KZL

Prescription Use : Yes

Device Count : 1

Barkey S-line - 04059201002203 Catalog Number :

Device Description : The device delivers warm blood, blood products, and liquids to adult and pediatr The device delivers warm blood, blood products, and liquids to adult and pediatric patients

Device Class : 2

Duns Number: 312555782

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

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