MERCURY ENTERPRISES, INC.

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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

Airway, Oropharyngeal, Anesthesiology (CAE) (5) Ventilator, Emergency, Manual (Resuscitator) (BTM) (5)

Premarket Exempt

No Yes

Clear

Guedel Airways (color coded) - 10641043816509 Catalog Number :

Device Description : 50MM

Device Class : 1

Duns Number: 032705659

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Guedel Airways (color coded) - 10641043816608 Catalog Number :

Device Description : 60MM

Device Class : 1

Duns Number: 032705659

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Guedel Airways (color coded) - 10641043816707 Catalog Number :

Device Description : 70MM

Device Class : 1

Duns Number: 032705659

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Guedel Airways (color coded) - 10641043816806 Catalog Number :

Device Description : 80MM

Device Class : 1

Duns Number: 032705659

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Guedel Airways (color coded) - 10641043816905 Catalog Number :

Device Description : 90MM

Device Class : 1

Duns Number: 032705659

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

CPR Bag Reusable - 30641043507005 Catalog Number :

Device Class : 2

Duns Number: 032705659

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

CPR Bag Reusable - 30641043507012 Catalog Number :

Device Class : 2

Duns Number: 032705659

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

CPR Bag Reusable - 30641043507029 Catalog Number :

Device Class : 2

Duns Number: 032705659

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

CPR Bag Reusable - 30641043507043 Catalog Number :

Device Class : 2

Duns Number: 032705659

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

CPR Bag Reusable - 30641043507050 Catalog Number :

Device Class : 2

Duns Number: 032705659

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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