NebuSal 3% USP 50190-142-63

GUDID 60850877007006

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

PHARMACARIBE, LLC.

Inhalation therapy saline solution, hypertonic
Primary Device ID60850877007006
NIH Device Record Key8a129b19-b421-44e3-ac68-6c908d1e5547
Commercial Distribution StatusIn Commercial Distribution
Brand NameNebuSal 3% USP
Version Model Number14263
Catalog Number50190-142-63
Company DUNS011702541
Company NamePHARMACARIBE, LLC.
Device Count60
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone804-339-4523
Emailwerner.gutmann@pharmacaribe.co
Phone804-339-4523
Emailwerner.gutmann@pharmacaribe.co

Device Dimensions

Total Volume4 Milliliter
Total Volume4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850877007004 [Unit of Use]
GS140850877007002 [Primary]
GS160850877007006 [Package]
Contains: 40850877007002
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-07

Devices Manufactured by PHARMACARIBE, LLC.

60850877007006 - NebuSal 3% USP2018-07-06Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
60850877007006 - NebuSal 3% USP2018-07-06 Carton with 60 vials: 3% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
60850877007013 - NebuSal 6% USP2018-07-06 Carton with 60 vials: 6% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
40850877007026 - Sodium Chloride Solution USP 7%2018-07-06 Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to USP, 4mL vial, sterile, preservative-free,non-pyrogenic
60850877007037 - PulmoSal 7% (pH+)2018-07-06 Carton with 60 vials: 7% Sodium Chloride Inhalation Solution, made to a pH of 7.4, 4mL vial, sterile, preservative-free,non-pyro

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