TENACORE HOLDINGS, INC.

Address:3115 Airway Ave,Costa Mesa,CA,92626,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

Regulator, Vacuum (KDP) (3) System, Monitoring, Perinatal (HGM) (3) Mixer, Breathing Gases, Anesthesia Inhalation (BZR) (2)

Premarket Exempt

No Yes

Clear

Mothership Wireless Fetal Transducer Base Station - 00852189007376 Catalog Number :

Device Description : Mothership Wireless Fetal Transducer Base Station

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mothership Wireless Transducers, Loop Style - 00852189007383 Catalog Number :

Device Description : Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership W Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Loop-Style, F1 Mothership Wireless Tocodynamometer Transducer, Loop Style, and F1 Mothership Wireless Fetal Transducer Base Station.

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mothership Wireless Transducers, Button Style - 00852189007390 Catalog Number :

Device Description : Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership W Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Button-Style, F1 Mothership Wireless Tocodynamometer Transducer, Button Style, and F1 Mothership Wireless Fetal Transducer Base Station.

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Tenacore - 00861269000206 Catalog Number :

Device Description : High-Low Flow Oxygen Blender

Device Class :

Duns Number: 138781799

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Tenacore - 00861269000213 Catalog Number :

Device Description : Low flow Oxygen blender

Device Class :

Duns Number: 138781799

Premarket Exempt : No

Product Code : BZR

Prescription Use : Yes

Device Count : 1

Veevo - 00861269000237 Catalog Number :

Device Description : Pediatric Continuous-Intermittent Vacuum Regulator

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Veevo - 00861269000282 Catalog Number :

Device Description : Pediatric Intermittent Only Wall Suction

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Veevo - 00861269000299 Catalog Number :

Device Description : Pediatric Continuous Only Wall Suction

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

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