Thermogenesis Corp.

Address:2711 Citrus Rd,RANCHO CORDOVA,CA,95742,US

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Filters

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

Cord Blood Processing System And Storage Container (OAO) (8) Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) (2)

Premarket Exempt

No Yes

Clear

PXP-LAVARE - 00886368000193 Catalog Number :

Device Description : PXP-LAVARE Disposable Cartridge

Device Class :

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : Yes

Device Count : 12

PXP-LAVARE - 00886368000209 Catalog Number :

Device Description : PXP-LAVARE Disposable Cartridge

Device Class :

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : Yes

Device Count : 36

PXP-LAVARE - 00886368000216 Catalog Number :

Device Description : PXP-LAVARE Control Module, packaged

Device Class :

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : No

Device Count : 1

PXP-LAVARE - 00886368000223 Catalog Number :

Device Description : PXP-LAVARE Docking Station, packaged

Device Class :

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : No

Device Count : 1

AXP Disposable Processing Bagset - 00886368000308 Catalog Number :

Device Description : Cord blood processing system and storage container

Device Class : 2

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : No

Device Count : 1

MXP Processing Bagset - 00886368000315 Catalog Number :

Device Description : Cell separation processing and collection bag set.

Device Class : 1

Duns Number: 080690327

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

QC Bagset - 00886368000322 Catalog Number : 8-5110

Device Description : Utilized for quality control testing of the AXP Device.

Device Class : 2

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : No

Device Count : 1

AXP Device - 00886368000346 Catalog Number : 8-5102

Device Description : Cord blood processing system

Device Class :

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : No

Device Count : 1

MXP Device - 00886368000353 Catalog Number : 8-5139

Device Description : Cell separation processing device

Device Class :

Duns Number: 080690327

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : Yes

Device Count : 1

AXP Docking Station - 00886368000360 Catalog Number : 8-5103

Device Description : Cord blood processing system docking station

Device Class :

Duns Number: 080690327

Premarket Exempt : No

Product Code : OAO

Prescription Use : No

Device Count : 1

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