FDA.reportPublic FDA data

PHARMACARIBE LLC

Matched from indexed company URL: PHARMACARIBE, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30065006943006500694PHARMACARIBE LLC1Y2026-01-01980 Palm View Drive #104 Naples FL US 34110

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
40850877007002NebuSal 3% USP - Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.com
40850877007019NebuSal 6% USP - Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.com
40850877007026Sodium Chloride Solution USP 7% - Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.co
40850877007026Sodium Chloride Solution USP 7% - Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.com
40850877007033PulmoSal 7% (pH+) - Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.com
60850877007006NebuSal 3% USP - Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.co
60850877007013NebuSal 6% USP - Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.co
60850877007037PulmoSal 7% (pH+) - Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyrogenic804-339-4523werner.gutmann@pharmacaribe.co

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1276891608104966K130091PULMOSALCAF2013-03-13
1276891425273716K101532NESSI OTC SPACERNVO2010-09-01
1276891139508966K101424PHARMACARIBE INHALED SALINE SOLUTIONSCAF2010-08-17
1276891311417495K091862NESSI SPACERNVO2009-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAF22013-03-13
NVO22010-09-01

PMN#

GUDID#