INSPIRATION HEALTHCARE GROUP PLC

Address:2 Satellite Business Park Village,Crawley West Sussex,GB

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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) PAD, HEATING, POWERED (IRT) (2)

Premarket Exempt

No Yes

Clear

TraumaTherm - 05060195340874 Catalog Number :

Device Description : TCU201 Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

TraumaTherm - 05060195340881 Catalog Number :

Device Description : TCU202 Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

TraumaTherm - 05060195340898 Catalog Number :

Device Description : TCU203 Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

TraumaTherm - 05060195340904 Catalog Number :

Device Description : TCU204 Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

TraumaTherm - 05060195340911 Catalog Number :

Device Description : TCU205 Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CosyTherm - 05060195340928 Catalog Number :

Device Description : NCM9 Mattress

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CosyTherm - 05060195340997 Catalog Number :

Device Description : SHC101 Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 1

CosyTherm - 05060195341000 Catalog Number :

Device Description : SHC301 Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : Yes

Device Count : 1

Koala - 05060195341017 Catalog Number :

Device Description : Koala Infant Warmer KIW-CON Control Unit

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Koala - 05060195341024 Catalog Number :

Device Description : Koala Infant Warmer KIW-LM2 Mattress

Device Class : 2

Duns Number: 235903494

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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