SEPARATION TECHNOLOGY, INC.

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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

Centrifuge, Hematocrit (GKG) (2) Instrument, Hematocrit, Automated (GKF) (1) Tube, Collection, Capillary Blood (GIO) (1)

Premarket Exempt

No Yes

Clear

UltraCrit Cleaning Tools - 00831829000366 Catalog Number : 320-113

Device Description : UltraCrit Cleaning Tools are to be used to clean the UltraCrit and UltraCrit Plus devices.

Device Class :

Duns Number: 195501127

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 50

UltraCrit (Refurbished) - 00831829000380 Catalog Number : R100-200

Device Description : UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technolog UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood. For In-Vitro diagnostics use.

Device Class : 2

Duns Number: 195501127

Premarket Exempt : No

Product Code : GKF

Prescription Use : No

Device Count : 1

HemataSTAT II Centrifuge (Refurbished) - 00831829000397 Catalog Number : R100-100

Device Description : HemataStat II Microhematocrit System is a small, lightweight centrifuge which pr HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit determination using capillary or venous blood samples.

Device Class : 2

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GKG

Prescription Use : No

Device Count : 1

ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes - 00831829000403 Catalog Number : 270-109VL

Device Class : 1

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GIO

Prescription Use : Yes

Device Count : 1

HemataSTAT II Centrifuge - 00831829000410 Catalog Number : 100-133

Device Class : 2

Duns Number: 195501127

Premarket Exempt : Yes

Product Code : GKG

Prescription Use : Yes

Device Count : 1

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