TENACORE HOLDINGS, INC.

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) (9) Regulator, Vacuum (KDP) (1)

Premarket Exempt

No Yes

Clear

Tenacore - 00852189007000 Catalog Number :

Device Description : HP/Philips 8040 TOCO W/HORSESHOE AND KNOB with 12 Pin Round Connector

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007017 Catalog Number :

Device Description : HP/Philips M1355A TOCO W/HORSESHOE AND KNOB with 12 Pin Round Connector

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007024 Catalog Number :

Device Description : Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/KNOB

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007031 Catalog Number :

Device Description : Corometrics Nautilus TOCO for 116, 118, 120 series, 150, 170 series monitors W/WING

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007048 Catalog Number :

Device Description : Corometrics 2260 TOCO for 116, 118, 120 series monitors W/WINGS

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007055 Catalog Number :

Device Description : HP/Philips 8040 Ultrasound W/HORSESHOE AND KNOB

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Veevo - 00852189007062 Catalog Number :

Device Description : Adult Continuous Intermittent Wall Suction

Device Class : 2

Duns Number: 138781799

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007079 Catalog Number :

Device Description : HP/Philips M1356A Ultrasound W/HORSESHOE AND KNOB

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : No

Device Count : 1

Tenacore - 00852189007086 Catalog Number :

Device Description : Corometrics Nautilus Ultrasound for 116, 118, 120 series, 150, 170 series monitors W/KNOB

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Tenacore - 00852189007093 Catalog Number :

Device Description : Corometrics Nautilus Ultrasound for 116, 118, 120 series, 150, 170 series monito Corometrics Nautilus Ultrasound for 116, 118, 120 series, 150, 170 series monitors W/WING 8′

Device Class : 2

Duns Number: 138781799

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

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