RAND SPA

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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

Warmer, Thermal, Infusion Fluid (LGZ) (8) Catheter, Irrigation (GBX) (2)

Premarket Exempt

No Yes

Clear

Performer HT - M640R51000710001 Catalog Number : R5100071

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Performer HT - M640R51000710031 Catalog Number : R5100071

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Performer HT - M640R51000710041 Catalog Number : R5100071

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Hang&Go HT Basic - M640R99000900001 Catalog Number : R9900090

Device Description : Kit for hyperthermic perfusion

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Hang&Go HT Basic - M640R99000900011 Catalog Number : R9900090

Device Description : Kit for hyperthermic perfusion

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Hang&Go HT Basic - M640R99000900021 Catalog Number : R9900090

Device Description : Kit for hyperthermic perfusion

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Ch24 round silicone catheter - M640R99000990001 Catalog Number : R9900099

Device Class :

Duns Number: 655010531

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Ch24 round silicone catheter - M640R99000990011 Catalog Number : R9900099

Device Class :

Duns Number: 655010531

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Hang&Go PAC - M640R99001170001 Catalog Number : R9900117

Device Description : Kit for hyperthermic perfusion

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

Hang&Go PAC - M640R99001170011 Catalog Number : R9900117

Device Description : Kit for hyperthermic perfusion

Device Class : 2

Duns Number: 655010531

Premarket Exempt : No

Product Code : LGZ

Prescription Use : Yes

Device Count : 1

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