Embla Systems Ltd

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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

Ventilatory Effort Recorder (MNR) (10)

Premarket Exempt

Clear

Natus - 00382830026246 Catalog Number :

Device Description : Single Use XactTrace belt - medium 20/bx

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830026253 Catalog Number :

Device Description : Single Use XactTrace belt - large 20/bx

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830026260 Catalog Number :

Device Description : XactTrace Snap Sensor Cable - Abdomen

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830026277 Catalog Number :

Device Description : XactTrace Snap Sensor Cable - Thorax

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830026284 Catalog Number :

Device Description : XactTrace Snap Sensor Cable - Abdomen, 78" cable length

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Natus - 00382830026291 Catalog Number :

Device Description : XactTrace Snap Sensor Cable, Thorax, 78" cable length

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830026772 Catalog Number :

Device Description : Snap on Cable 24"/60cm Green

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830026789 Catalog Number :

Device Description : Snap on Cable 24"/61cm Red

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027076 Catalog Number :

Device Description : XactTrace Lock - Thorax EBG

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Xltek - 00382830027083 Catalog Number :

Device Description : XactTrace Reusable Belt - Small Abdomen

Device Class : 2

Duns Number: 203408612

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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