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) (8) Ventilatory Effort Recorder (MNR) (2)

Premarket Exempt

Clear

TriplePlay - 00817377020100 Catalog Number :

Device Description : Snore Sensor, Disposable, Small

Device Class :

Duns Number: 079976463

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

TriplePlay - 00817377020117 Catalog Number :

Device Description : Snore Sensor, Disposable, Large

Device Class :

Duns Number: 079976463

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020124 Catalog Number :

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

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020131 Catalog Number :

Device Description : Perfect Fit™ 3D Effort Belt Strap, 50 yard roll

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020148 Catalog Number :

Device Description : Perfect Fit™Pediatric Effort Belt Sensor, Abdomen

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020155 Catalog Number :

Device Description : Perfect Fit™II Pediatric Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020162 Catalog Number :

Device Description : Perfect Fit II Pediatric Alice 5 Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020179 Catalog Number :

Device Description : Perfect Fit II Pediatric Alice 3 Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020186 Catalog Number :

Device Description : Perfect Fit™II R/S Pediatric Effort Belt Sensor, Chest

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

Perfect Fit - 00817377020193 Catalog Number :

Device Description : Perfect Fit™ II Pediatric Effort Belt Sensor, Abdomen

Device Class : 2

Duns Number: 079976463

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

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