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

Reprocessed Blood Pressure Cuff (NPP) (6) Cable, Electrode (IKD) (2) Oximeter, Reprocessed (NLF) (1) Sleeve, Limb, Compressible (JOW) (1)

Premarket Exempt

No Yes

Clear

Medline - 10817357020219 Catalog Number :

Device Description : Medline CUFF, BP, DISP, 1 TB, ADLT LNG, HP

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Critikon - 10817357020226 Catalog Number :

Device Description : Critikon Soft Cuf One Tube Bayonet, Adult

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Critikon - 10817357020233 Catalog Number :

Device Description : Critikon Soft Cuf Two Tube Screw, Adult

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Critikon - 10817357020240 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Covidien - 10817357020257 Catalog Number :

Device Description : Covidien Disposable Lead Wire 5-Grabber Dual Connect Cable and Lead Wire System

Device Class :

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Currie Medical - 10817357020264 Catalog Number :

Device Description : Currie ALP REGULAR CALF garment (up to 18" calf circumference)

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : JOW

Prescription Use : No

Device Count : 1

Regard - 10817357020271 Catalog Number :

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

Device Class :

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020288 Catalog Number :

Device Description : Welch Allyn Flexiport BP Cuff, One-Tube Bayonet, Adult

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Nellcor - 10817357020295 Catalog Number :

Device Description : Nellcor OxiMax Pediatric Pulse Oximeter Sensor

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Covidien - 10817357020301 Catalog Number :

Device Description : Covidien Disposable Dual Connect Cable and Lead Wire System

Device Class :

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

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