TRINITY MEDICAL DEVICES INC.

Address:135 US Highway 202 206,Bedminster,NJ,07921,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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (4) Ventilator, Non-Continuous (Respirator) (BZD) (4) Nebulizer (Direct Patient Interface) (CAF) (1) Tube, Aspirating, Flexible, Connecting (BYY) (1)

Premarket Exempt

No Yes

Clear

Trinity Medical Devices - 00813880021658 Catalog Number :

Device Description : 1/4 x 6 suction connection tube

Device Class :

Duns Number: 078728314

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : No

Device Count : 50

Klear-Trace - 00813880022174 Catalog Number :

Device Description : Short Term Neonatal/Infant Electrodes

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 3

Klear-Trace - 00813880023102 Catalog Number :

Device Description : Long Term Neonatal Electrodes

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 3

Klear-Trace - 00813880023119 Catalog Number :

Device Description : Long Term Infant/Pediatric Electrodes

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 3

Klear-Trace - 00813880023126 Catalog Number :

Device Description : Long Term 5 Lead Electrode

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 5

Trinity Medical Devices - 00813880023508 Catalog Number :

Device Description : Medication Nebulizer

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 50

Trinity Medical Devices - 00813880025571 Catalog Number :

Device Description : Full Face CPAP Mask 22MM female elbow, vented Small

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 10

Trinity Medical Devices - 00813880025588 Catalog Number :

Device Description : Full Face CPAP Mask 22MM female elbow, vented Medium

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 10

Trinity Medical Devices - 00813880025595 Catalog Number :

Device Description : Full Face CPAP Mask 22MM female elbow, vented Large

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 10

Trinity Medical Devices - 00813880025601 Catalog Number :

Device Description : Full Face CPAP Mask 22MM female elbow, Non-vented S

Device Class :

Duns Number: 078728314

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 10

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