HYGIA HEALTH SERVICES, INC.

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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

Cable, Electrode (IKD) (4) Reprocessed Blood Pressure Cuff (NPP) (4) Infusor, Pressure, For I.V. Bags (KZD) (1) Oximeter, Reprocessed (NLF) (1)

Premarket Exempt

Yes No

Clear

Covidien - 10817357020417 Catalog Number :

Device Description : Covidien Disposable 5 Lead System For Use with GE Telemetry System-Direct Connect

Device Class :

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Critikon - 10817357020424 Catalog Number :

Device Description : Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Child

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Covidien - 10817357020431 Catalog Number :

Device Description : Covidien Disposable 6 Lead System For Use with GE Apex™Pro CH Telemetry System-D Covidien Disposable 6 Lead System For Use with GE Apex™Pro CH Telemetry System-Direct Connect

Device Class :

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Merit - 10817357020448 Catalog Number :

Device Description : Merit 500ml Infusor Bag with Dual Pressure Valve

Device Class : 1

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : KZD

Prescription Use : No

Device Count : 1

Regard - 10817357020455 Catalog Number :

Device Description : Regard-SM ADULT-1T-Bay

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Masimo - 10817357020462 Catalog Number :

Device Description : Masimo Pediatric SpO2 Adhesive Sensors, 18 in.

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Cardinal Health - 10817357020479 Catalog Number :

Device Description : Cardinal Health Flexiport Adult Long

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

AMC&E - 10817357020486 Catalog Number :

Device Description : AMC&E 5-lead DIN to Pinch Leadset

Device Class : 2

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Medline - 10817357020493 Catalog Number :

Device Description : Medline CUFF, BP, DISP, 1 TUBE, SM ADLT, HP

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Covidien - 10817357020509 Catalog Number :

Device Description : Covidien Disposable Dual Connect Lead Set

Device Class :

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

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