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) (2) Cable, Electrode (IKD) (1) Sleeve, Limb, Compressible (JOW) (1)

Premarket Exempt

No Yes

Clear

Welch Allyn - 10817357020318 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Nova Plus - 10817357020325 Catalog Number :

Device Description : Nova Plus Trimline Blood Pressure Cuff; Size-11 Adult, Soft Disposable, 1-Tube, Nova Plus Trimline Blood Pressure Cuff; Size-11 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

Masimo - 10817357020332 Catalog Number :

Device Description : Masimo Neonatal SpO2 Adhesive Sensors, 3 ft.

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Nellcor - 10817357020349 Catalog Number :

Device Description : Nellcor OxiMax Adult Long Pulse Oximeter Sensor

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NLF

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020356 Catalog Number :

Device Description : Welch Allyn Flexiport BP Cuff, Two-Tube Locking, Adult

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020363 Catalog Number :

Device Description : Welch Allyn Trimline Blood Pressure Cuff; Size-11 Adult, Soft Disposable, 2-Tube Welch Allyn Trimline Blood Pressure Cuff; Size-11 Adult, Soft Disposable, 2-Tubes, One Clamp, Female Screw

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Welch Allyn - 10817357020370 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

3M - 10817357020387 Catalog Number :

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

Device Class : 2

Duns Number: 177939027

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : No

Device Count : 1

Critikon - 10817357020394 Catalog Number :

Device Description : Critikon Soft Cuf One Tube Bayonet, Adult Long

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : NPP

Prescription Use : No

Device Count : 1

Kendall - 10817357020400 Catalog Number :

Device Description : Kendall SCD Comfort Knee Length Medium

Device Class : 2

Duns Number: 177939027

Premarket Exempt : No

Product Code : JOW

Prescription Use : No

Device Count : 1

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