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) (5) Resuscitator,Manual,Non Self-Inflating (NHK) (4) Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP) (1)

Premarket Exempt

No Yes

Clear

LIFESAVER - 04710810093098 Catalog Number : HD-5473

Device Description : RESUS ADULT W/TUBE RSVR AND MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

LIFESAVER - 04710810093104 Catalog Number : HD-5474

Device Description : RESUS ADULT W/FILTER AND MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Venti.Plus - 04710810100260 Catalog Number : H050-HD

Device Description : 0.5 HYPERINFLATION W/ MANOMETER

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

Venti.Plus - 04710810100277 Catalog Number : H050-HD1

Device Description : 0.5 HYPERINFLATION W/ MANMTR, MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

Venti.Plus - 04710810100284 Catalog Number : H100-HD

Device Description : 1.0 HYPERINFLATION W/ MANOMETER

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

Venti.Plus - 04710810100291 Catalog Number : H100-HD1

Device Description : 1.0 HYPERINFLATION W/ MANMTR, MASK

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810100307 Catalog Number : 4524-HD

Device Description : MANOMETER

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810101755 Catalog Number :

Device Description : Rescu-6 Manual Resuscitator, Adult w/ Mask #5

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810101779 Catalog Number :

Device Description : Rescu-6 Manual Resuscitator, Child w/ Mask #3

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

GaleMed - 04710810101793 Catalog Number :

Device Description : Rescu-6 Manual Resuscitator, Infant w/ Mask #1

Device Class : 2

Duns Number: 527333326

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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