ATHENA GTX, INC.

Address:5900 NW 86th St Ste 300,Johnston,IA,50131,US

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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

Oximeter (DQA) (9) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (9) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (9) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (7) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (2) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (2) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (1)

Premarket Exempt

Clear

TACVAC - B3945300021010 Catalog Number : 530-0021-01

Device Description : Portable Battery Powered Suction Device

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945300023010 Catalog Number : 530-0023-01

Device Description : WVSM Aux Battery (Straight)

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DXN, DQA, DRG, CCK

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945300025010 Catalog Number : 530-0025-01

Device Description : AC/DC Power Supply

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B394530023020 Catalog Number : 530-0023-02

Device Description : WVSM Aux Battery (Angled)

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DXN, DQA, DRG, CCK

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945500039010 Catalog Number : 550-0039-01

Device Description : USB Data Cable

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DXN, DRG, DQA, MWI

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700004010 Catalog Number : 570-0004-01

Device Description : ECG Lead Wires - Unbonded

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DXN, DRG, DQA, MWI

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700004020 Catalog Number : 570-0004-02

Device Description : ECG Lead Wires - Bonded

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700024010 Catalog Number : 570-0024-01

Device Description : Shoulder Strap-Black

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DXN, DRG, DQA, MWI

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700025010 Catalog Number : 570-0025-01

Device Description : BP Extension Hose-1 ft

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945700025020 Catalog Number : 570-0025-02

Device Description : BP Extension Hose-2 ft

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DXN, DRG, DQA, MWI

Prescription Use : Yes

Device Count : 1

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