AUGUSTINE TEMPERATURE MANAGEMENT LLC

Address:7656 W. 78th St.,Minneapolis,MN,55439,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

System, Thermal Regulating (DWJ) (8) Support, Patient Position (CCX) (2)

Premarket Exempt

No Yes

Clear

WaffleGrip - 00850011479636 Catalog Number : 2084054

Device Description : WaffleGrip Bracket Set

Device Class : 1

Duns Number: 965879187

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

WaffleGrip PadLock Bracket Set - 00850011479643 Catalog Number : A330

Device Description : WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for Warming Pad

Device Class : 1

Duns Number: 965879187

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

Hot Dog Patient Warming System Controller - 00855913001015 Catalog Number : WC02

Device Description : Labeled: Hot Dog Patient Warming System Controller WC02

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hot Dog Lower Body Warming Blanket, Pediatric - 00855913001091 Catalog Number : B203

Device Description : Hot Dog Lower Body Warming Blanket, Pediatric B203

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hot Dog Patient Warming System Controller WC01 - 00855913001107 Catalog Number : WC01

Device Description : Labeled: Hot Dog WC01 Patient Warming System Controller

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hot Dog Lower Body Warming Blanket - 00855913001251 Catalog Number : B103

Device Description : Labeled: Hot Dog Lower Body Warming Blanket B103

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hot Dog Full Body Warming Blanket - 00855913001268 Catalog Number : B104

Device Description : Labeled: Hot Dog Full Body Warming Blanket B104

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hot Dog Multi-Position Warming Blanket - 00855913001381 Catalog Number : B105

Device Description : Labeled Hot Dog Multi-Position Warming Blanket B105

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hot Dog Head Warming Blanket - 00855913001398 Catalog Number : B107

Device Description : Labeled: Hot Dog Head Warming Blanket B107

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Hot Dog Chest and Torso Warming Blanket - 00855913001480 Catalog Number : B110

Device Description : Labeled: Hot Dog Chest and Torso Warming Blanket B110

Device Class : 2

Duns Number: 965879187

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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