PHARMACARIBE, LLC.

Address:3513 Dileuca St,Punta Gorda,FL,33950,US

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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

Nebulizer (Direct Patient Interface) (CAF) (4)

Premarket Exempt

Clear

NebuSal 3% USP - 40850877007002 Catalog Number : 50190-142-63

Device Description : Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL v Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic

Device Class :

Duns Number: 011702541

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 60

NebuSal 6% USP - 40850877007019 Catalog Number : 50190-523-23

Device Description : Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL v Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic

Device Class :

Duns Number: 011702541

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 60

Sodium Chloride Solution USP 7% - 40850877007026 Catalog Number : 50190-141-23

Device Description : Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to USP, 4mL v Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic

Device Class :

Duns Number: 011702541

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 60

PulmoSal 7% (pH+) - 40850877007033 Catalog Number : 50190-740-60

Device Description : Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7. Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic

Device Class :

Duns Number: 011702541

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 60

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