Sodium Chloride for Inhalation Solution 0.9% REF 62135-832-84

GUDID 00860011790310

Chartwell Rx, LLC

Inhalation therapy saline solution, isotonic
Primary Device ID00860011790310
NIH Device Record Keyd92ec7b4-2cb6-47ba-9c61-733c1baee8b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSodium Chloride for Inhalation Solution 0.9%
Version Model Number3 mL
Catalog NumberREF 62135-832-84
Company DUNS079394054
Company NameChartwell Rx, LLC
Device Count30
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 Numbertrue
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

Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com
Phone1-845-232-1683
Emailcs@chartwellpharma.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011790303 [Primary]
GS100860011790310 [Unit of Use]
GS100860011790327 [Package]
Contains: 00860011790303
Package: [6 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-04
Device Publish Date2024-03-27

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