BOEKEL INDUSTRIES, 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

Chamber, Environmental For The Storage Of Platelet Concentrate (KSH) (2) Device, Blood Mixing And Blood Weighing (KSQ) (2) Device, Warming. Blood And Plasma (KZL) (1)

Premarket Exempt

No Yes

Clear

Boekel Plasma Thawer - 00863626000201 Catalog Number :

Device Class : 2

Duns Number: 002288215

Premarket Exempt : No

Product Code : KZL

Prescription Use : No

Device Count : 1

Boekel Small Platelet Agitator - 00863626000218 Catalog Number : 301200

Device Description : Device used to agitate platelets. May be used alone if temperature can be maint Device used to agitate platelets. May be used alone if temperature can be maintained to 22 degrees C +/- 2 degrees. may be used in conjunction with the Boekel Small Platelet Incubator.

Device Class : 1

Duns Number: 002288215

Premarket Exempt : Yes

Product Code : KSQ

Prescription Use : No

Device Count : 1

Boekel Large Platelet Agitator - 00863626000225 Catalog Number :

Device Description : Large Platelet Agitator to continuously keep bags of Platelets moving. To be us Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large Platelet Incubator 301550

Device Class : 1

Duns Number: 002288215

Premarket Exempt : Yes

Product Code : KSQ

Prescription Use : No

Device Count : 1

Boekel Small Platelet Incubator - 00863626000232 Catalog Number :

Device Class : 2

Duns Number: 002288215

Premarket Exempt : Yes

Product Code : KSH

Prescription Use : No

Device Count : 1

Boekel Large Platelet Incubator - 00863626000249 Catalog Number :

Device Class : 2

Duns Number: 002288215

Premarket Exempt : Yes

Product Code : KSH

Prescription Use : No

Device Count : 1

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