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

Set, Tubing And Support, Ventilator (W Harness) (BZO) (5) Connector, Airway (Extension) (BZA) (3) Drain, Tee (Water Trap) (BYH) (1) Mask, Gas, Anesthetic (BSJ) (1)

Premarket Exempt

No Yes

Clear

N/A - 04710810084836 Catalog Number : Disposable Straight Connector

Device Class :

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 100

N/A - 04710810085338 Catalog Number : Durable Water Trap 15M

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BYH

Prescription Use : No

Device Count : 1

N/A - 04710810085581 Catalog Number : SF silicone hose 22F cuff, L= 20 cm

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

N/A - 04710810085932 Catalog Number : Hytrel hose22F cuff, L= 110 cm

Device Class :

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

N/A - 04710810086403 Catalog Number : Durable Straight Connector 22/15mm, 22F

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 1

galemed - 04710810087394 Catalog Number : Disposable Humidification Chamber - Auto feeding (IV:120cm)

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

N/A - 04710810088148 Catalog Number : Hytrel hose15F cuff,L= 60 cm弓

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

N/A - 04710810088629 Catalog Number : Hytrel hose10F cuff,L= 30 cm

Device Class : 1

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

N/A - 04710810088698 Catalog Number : Air-Soft Mask Size 0, Infant

Device Class : 1

Duns Number: 656854379

Premarket Exempt : No

Product Code : BSJ

Prescription Use : No

Device Count : 1

N/A - 04710810088919 Catalog Number : Neonate Elbow Connector 4.3M, 4.0M

Device Class :

Duns Number: 656854379

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 100

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