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) (5) Cable, Electrode (IKD) (4) Oximeter, Tissue Saturation, Reprocessed (NMD) (1)

Premarket Exempt

Yes No

Clear

3M - 10817357020516 Catalog Number :

Device Description : 3M Healthcare 5 Lead Disposable Leadwire, GE to Pinch, 50"

Device Class : 2

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Nova Plus - 10817357020523 Catalog Number :

Device Description : Welch Allyn Trimline Blood Pressure Cuff; Size-11L Adult Long, Soft Disposable, Welch Allyn Trimline Blood Pressure Cuff; Size-11L Adult Long, Soft Disposable, 1-Tube, Male Bayonet

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Regard - 10817357020530 Catalog Number :

Device Description : Regard-ADULT-2T-Screw

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Somanetics - 10817357020547 Catalog Number :

Device Description : Cerebral/Somatic Oximetry Adult Sensor

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NMD

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020554 Catalog Number :

Device Description : Welch Allyn Trimline Blood Pressure Cuff; Size-09 Child, Soft Disposable, 1-Tube Welch Allyn Trimline Blood Pressure Cuff; Size-09 Child, Soft Disposable, 1-Tube, Male Bayonet

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Nova Plus - 10817357020561 Catalog Number :

Device Description : Nova Plus Trimline Blood Pressure Cuff; Size-10 Small Adult, Soft Disposable, 1- Nova Plus Trimline Blood Pressure Cuff; Size-10 Small Adult, Soft Disposable, 1-Tube, Male Bayonet

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

AMC&E - 10817357020578 Catalog Number :

Device Description : AMC&E 3-lead DIN to Pinch Leadset

Device Class : 2

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Covidien - 10817357020585 Catalog Number :

Device Description : Covidien Disposable 5 Lead Sysem

Device Class :

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020592 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Covidien - 10817357020608 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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