DYMEDIX DIAGNOSTICS, INC.

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

Monitor, Breathing Frequency (BZQ) (10)

Premarket Exempt

Clear

Perfect Fit - 00817377020308 Catalog Number :

Device Description : Cadwell ApneaTrak Effort Belt Strap, Pediatric, 25", 2 Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020315 Catalog Number :

Device Description : Cadwell ApneaTrak Effort Belt Strap, Pediatric XL, 35", 2 Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020322 Catalog Number :

Device Description : Perfect Fit™ II Effort Belt Strap, Infant, 15", 2- Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020339 Catalog Number :

Device Description : Perfect Fit™ II Effort Belt Strap, Pediatric, 25", 2- Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020346 Catalog Number :

Device Description : Perfect Fit™ II Effort Belt Strap, Pediatric XL, 35", 2 Pack

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020353 Catalog Number :

Device Description : Perfect Fit™ Disposable Pediatric Effort Belt, 2 pcs

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020360 Catalog Number :

Device Description : Perfect Fit™ Disposable Adult Effort Belt, 2 pcs

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020377 Catalog Number :

Device Description : Cadwell Disposable Pediatric Effort Belt, 2 pcs

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020384 Catalog Number :

Device Description : Cadwell Disposable Adult Effort Belt, 2 pcs

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020391 Catalog Number :

Device Description : Perfect Fit™Adult Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

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