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

Ventilator, Emergency, Manual (Resuscitator) (BTM) (9) Connector, Airway (Extension) (BZA) (1)

Premarket Exempt

No Yes

Clear

GaleMed - 04710810085208 Catalog Number :

Device Description : Child Wye Connector 15M w/Pressure Port

Device Class : 1

Duns Number: 527333326

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093005 Catalog Number : HD-5461

Device Description : RESUS PEDS MANOMETER AND MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093012 Catalog Number : HD-5462

Device Description : RESUS PEDS W/ TUBE MANMTR MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093029 Catalog Number : HD-5463

Device Description : RESUS PEDS W/ TUBE RSVR MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093036 Catalog Number : HD-5466

Device Description : RESUS NEO MANOMETER AND MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093043 Catalog Number : HD-5467

Device Description : RESUS NEO W/ TUBE MANMTR MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093050 Catalog Number : HD-5468

Device Description : RESUS NEO W/ TUBE RSVR MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093067 Catalog Number : HD-5470

Device Description : RESUS ADULT W/TUBE MANOMETER FLTR

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093074 Catalog Number : HD-5471

Device Description : RESUS ADULT W/ MANOMETER FLTR

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093081 Catalog Number : HD-5472

Device Description : RESUS ADULT W/TUBE RSVR FILTER

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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