SMITHS MEDICAL

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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

HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) (BTT) (3) NEBULIZER (DIRECT PATIENT INTERFACE) (CAF) (2)

Premarket Exempt

No Yes

Clear

Portex - 00351688600007 Catalog Number :

Device Class :

Duns Number: 835634168

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 100

Portex - 00351688600014 Catalog Number :

Device Class :

Duns Number: 835634168

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 100

Portex - 50351688600101 Catalog Number :

Device Class :

Duns Number: 835634168

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 20

Portex - 50351688600118 Catalog Number :

Device Class :

Duns Number: 835634168

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 12

Portex - 50351688600125 Catalog Number :

Device Class :

Duns Number: 835634168

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 12

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