GaleMed Xiamen Co., Ltd.

GaleMed Xiamen Co., Ltd.

Address:Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road,XIAMEN Fujian,CN

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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

Connector, Airway (Extension) (BZA) (6) Mask, Gas, Anesthetic (BSJ) (1) Set, Tubing And Support, Ventilator (W Harness) (BZO) (1) Support, Breathing Tube (JAY) (1) Transducer, Gas Pressure (BXO) (1)

Premarket Exempt

No Yes

Clear

GaleMed - 04710810080692 Catalog Number :

Device Description : Disposable Bi-Wye Connector 22M

Device Class : 1

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810082030 Catalog Number :

Device Description : Disposable Tube Clip 22mm

Device Class :

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : JAY

Prescription Use : Yes

Device Count : 100

GaleMed - 04710810082658 Catalog Number :

Device Description : Disposable Straight Connector 15M,7.6F Port&Cap,22/15mm

Device Class : 1

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810082948 Catalog Number :

Device Description : Disposable Elbow 15M, 22/15mm, 6M

Device Class :

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 100

Sil-Flex - 04710810083198 Catalog Number :

Device Description : New Sil-Flex Silicone Mask size 3, Child Large

Device Class :

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Sil-Flex - 04710810083303 Catalog Number :

Device Description : Sil-Flex tube 10F/22F，14cm

Device Class : 1

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810083815 Catalog Number :

Device Description : Neonate Wye Connector 10M w/ Pressure Port

Device Class : 1

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810084126 Catalog Number :

Device Description : CV-3 Single Limb Manifold

Device Class :

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BXO

Prescription Use : Yes

Device Count : 100

GaleMed - 04710810084317 Catalog Number :

Device Description : Disposable Swivel Wye 22M

Device Class : 1

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810085161 Catalog Number :

Device Description : Disposable Tee Valve

Device Class : 1

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

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