Jarden Consumer Solutions

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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

Pad, Heating, Powered (IRT) (6) Pack, Hot Or Cold, Reusable (IME) (2) Analyzer, Body Composition (MNW) (1) Humidifier, Non-Direct Patient Interface (Home-Use) (KFZ) (1)

Premarket Exempt

Yes

Clear

Sunbeam - 00053891156011 Catalog Number :

Device Description : Heating Pad

Device Class : 2

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Sunbeam - 00053891156219 Catalog Number :

Device Description : Hot or Cold therapy Pack, Reusable

Device Class : 1

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Sunbeam - 00053891156226 Catalog Number :

Device Description : Hot or Cold therapy Pack, Reusable

Device Class : 1

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IME

Prescription Use : No

Device Count : 1

Sunbeam - 00053891157155 Catalog Number :

Device Description : Ultrasonic Personal Humidifier

Device Class : 1

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Sunbeam - 00053891160100 Catalog Number :

Device Description : Heating Pad

Device Class : 2

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Sunbeam - 00053891160506 Catalog Number :

Device Description : Partial Carbon Fiber Body Fat scale

Device Class : 2

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : MNW

Prescription Use : No

Device Count : 1

Sunbeam - 00053891162807 Catalog Number :

Device Description : Heating Pad

Device Class : 2

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Sunbeam - 00053891162814 Catalog Number :

Device Description : Heating Pad

Device Class : 2

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Sunbeam - 00053891162821 Catalog Number :

Device Description : Heating Pad

Device Class : 2

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

Sunbeam - 00053891162838 Catalog Number :

Device Description : Heating Pad

Device Class : 2

Duns Number: 001315134

Premarket Exempt : Yes

Product Code : IRT

Prescription Use : No

Device Count : 1

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