GALEMED CORPORATION

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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

Attachment, Breathing, Positive End Expiratory Pressure (BYE) (4) Connector, Airway (Extension) (BZA) (3) Set, Tubing And Support, Ventilator (W Harness) (BZO) (2) Drain, Tee (Water Trap) (BYH) (1)

Premarket Exempt

No Yes

Clear

N/A - 04710810080159 Catalog Number : 5-20cm HO, 30mmID, Blue

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

N/A - 04710810080166 Catalog Number : Disposable Adjustable PEEP Valve

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

N/A - 04710810080685 Catalog Number : Disposable Straight Connector 15M, 6M

Device Class :

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 100

N/A - 04710810082382 Catalog Number : SF silicone hose 22F cuff, L= 35 cm

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

N/A - 04710810083266 Catalog Number : Wye Connector 22M

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 1

N/A - 04710810083518 Catalog Number : Disposable Straight Connector 22F, 6M, 22/15mm Bulk Packed

Device Class :

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 100

N/A - 04710810083686 Catalog Number : Disposable Adjustable Peep Valve 5-20cmHO, 22OD (Blue)

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

N/A - 04710810083693 Catalog Number : Disposable Adjustable Peep Valve 5-20cm H O, 22mmID, Blue

Device Class : 2

Duns Number: 656854379

Premarket Exempt : No

Product Code : BYE

Prescription Use : Yes

Device Count : 1

N/A - 04710810084225 Catalog Number : Hytrel hose10F cuff,L= 60 cm

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

N/A - 04710810084478 Catalog Number : Durable Water Trap 22M

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BYH

Prescription Use : No

Device Count : 1

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