HYGIA HEALTH SERVICES, INC.

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) Oximeter, Reprocessed (NLF) (4)

Premarket Exempt

No Yes

Clear

Nellcor - 10817357020011 Catalog Number :

Device Description : Nellcor OxiMax Adult Pulse Oximeter Sensor

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Nellcor - 10817357020028 Catalog Number :

Device Description : Nellcor OxiMax Neonatal Pulse Oximeter Sensor

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020035 Catalog Number :

Device Description : Welch Allyn Flexiport BP Cuff, No Tube, Adult

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Critikon - 10817357020042 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Masimo - 10817357020059 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Critikon - 10817357020066 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Medline - 10817357020073 Catalog Number :

Device Description : Medline CUFF, BP, DISP, 1 TUBE, ADULT, HP

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Regard - 10817357020080 Catalog Number :

Device Description : Regard - ADULT-1T-Bay

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Masimo - 10817357020097 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020103 Catalog Number :

Device Description : Welch Allyn Flexiport BP Cuff, No Tube, Adult Long

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

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