DYMEDIX DIAGNOSTICS, INC.

Address:5985 Rice Creek Pkwy Ste 200,Shoreview,MN,55126,US

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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

Monitor, Breathing Frequency (BZQ) (10)

Premarket Exempt

Clear

Perfect Fit - 00817377020605 Catalog Number :

Device Description : Cadwell ApneaTrak Effort Belt Strap, XL, 60", 2 Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020612 Catalog Number :

Device Description : Cadwell ApneaTrak Effort Belt Strap, XXL, 75", 2 Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020629 Catalog Number :

Device Description : Perfect Fit II Effort Belt Strap, Medium, 30", 2 Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020636 Catalog Number :

Device Description : Perfect Fit II Effort Belt Strap, Large, 45"

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020643 Catalog Number :

Device Description : Perfect Fit II Effort Belt Strap, Large, 45", 2 Pk

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020650 Catalog Number :

Device Description : Perfect Fit II Effort Belt Strap, XL, 60", 2 Pk

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020667 Catalog Number :

Device Description : Perfect Fit II Effort Belt Strap, XXL, 75", 2 Pk

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020674 Catalog Number :

Device Description : Perfect Fit™ 3D Effort Belt Sensor, Abdomen, 1.5 mm

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020681 Catalog Number :

Device Description : Perfect Fit™ 3D Effort Belt Sensor, Chest, 1.5 mm

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020698 Catalog Number :

Device Description : Perfect Fit™ 3D Effort Belt Sensor, Abdomen, Alice 5

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

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