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

System, Monitoring, Perinatal (HGM) (6) Regulator, Vacuum (KDP) (4)

Premarket Exempt

No Yes

Clear

Tenacore - 00852189007109 Catalog Number :

Device Description : Corometrics Ultrasound for 116, 118, 120 series monitors W/WINGS 5700

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Veevo - 00852189007116 Catalog Number :

Device Description : Adult Continuous Full Wall Suction

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Veevo - 00852189007123 Catalog Number :

Device Description : Adult Intermittent Only

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Veevo - 00852189007130 Catalog Number :

Device Description : Adult Continuous Only Wall Suction Regulator

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007147 Catalog Number :

Device Description : Corometrics Ultrasound for 115/145 monitors W/WINGS AND KNOB

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Veevo - 00852189007154 Catalog Number :

Device Description : Surgical Continuous Full Wall Suction

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Mothership Wireless Fetal Ultrasound Transducer, Button-Style - 00852189007338 Catalog Number :

Device Description : Mothership Wireless Fetal Ultrasound Transducer, Button-Style

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mothership Wireless Fetal Tocodynamometer Transducer, Button Style - 00852189007345 Catalog Number :

Device Description : Mothership Wireless Fetal Tocodynamometer Transducer, Button Style

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mothership Wireless Fetal Ultrasound Transducer, Loop Style - 00852189007352 Catalog Number :

Device Description : Mothership Wireless Fetal Ultrasound Transducer, Loop Style

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mothership Wireless Fetal Tocodynamometer Transducer, Loop-Style - 00852189007369 Catalog Number :

Device Description : Mothership Wireless Fetal Tocodynamometer Transducer, Loop-Style

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

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