GALEMED CORPORATION

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Filters
Device Class
Product Code
Premarket Exempt
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- Catalog Number : Hytrel hose10F cuff,L= 90 cm

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

- Catalog Number : 12.5 cmH O Pressure Relief Manifold

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

- Catalog Number : Bubble PAP Valve

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

- Catalog Number : Hyperinflation System 0.25L with Mask

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

- Catalog Number : Hyperinflation System 0.5L with Mask

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

- Catalog Number : Hyperinflation System 1.0L with Mask

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

- Catalog Number : RF1 Nebulizer w/Neb-1.T Valve Kit, 22M, 22M

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 1

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 1

- Catalog Number : Bubble PAP Valve 0-10cmH2O

Device Description : Distributed by Teleflex

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

- Catalog Number : 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port

Device Description : Distributed by Teleflex

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1