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) (8) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (8) Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (5) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (3) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (3) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (1)

Premarket Exempt

Clear

WVSM Wireless Vital Signs Monitor - B3945000034020 Catalog Number : 500-0034-02

Device Description : Wireless Patient Monitor

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 - B3945000034030 Catalog Number : 500-0034-03

Device Description : Wireless Patient Monitor

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 - B3945000034040 Catalog Number : 500-0034-04

Device Description : Wireless Patient Monitor

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 - B3945100004010 Catalog Number : 510-0004-01

Device Description : Carry Case for 2 WVSMs

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 - B3945100004020 Catalog Number : 510-0004-02

Device Description : Carry Case for 4 WVSMs

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 - B3945100004030 Catalog Number : 510-0004-03

Device Description : Carry Case for 10 WVSMs

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 - B3945100004040 Catalog Number : 510-0004-04

Device Description : Custom Pouch for 2 WVSMs

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : MWI, DQA, DRG, DXN

Prescription Use : Yes

Device Count : 1

TACVAC - B3945100006010 Catalog Number : 510-0006-01

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

WiCap - B3945200015010 Catalog Number : 520-0015-01

Device Description : Pulse-Ox Accessory

Device Class : 2

Duns Number: 048031913

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

WVSM Wireless Vital Signs Monitor - B3945300002010 Catalog Number : 530-0002-01

Device Description : A/C Power Brick

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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