Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL

GUDID 00303786987894

The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.

MYLAN PHARMACEUTICALS INC.

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Primary Device ID00303786987894
NIH Device Record Keya7df9548-0e39-4428-80f0-51e21a32dd97
Commercial Distribution StatusIn Commercial Distribution
Brand NameSodium Chloride Inhalation Solution, USP, 0.9% 15 mL
Version Model Number15mL
Company DUNS059295980
Company NameMYLAN PHARMACEUTICALS INC.
Device Count1
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

Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com
Phone1-877-446-3679
Emailcustomer.service@mylan.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100303786987894 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-12-12

Devices Manufactured by MYLAN PHARMACEUTICALS INC.

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00303786985012 - Sodium Chloride Inhalation Solution, USP, 0.9% 3mL UDV2018-03-29 The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy
00303786986019 - Sodium Chloride Inhalation Solution, USP 0.9% 5mL2018-03-29 The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy
00303786987894 - Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL2018-03-29The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen free. Primary DI number is for one carton of 50 vials, the lowest saleable unit. Each vial is not sold separately and is not intended to be separated from it's unit of sale.
00303786987894 - Sodium Chloride Inhalation Solution, USP, 0.9% 15 mL2018-03-29 The single-use device is in a color coded unit blow fill sealed container with liquid contents as labeled for inhalation therapy
00303786997893 - Sodium Chloride Inhalation Solution, USP, 3% 15mL2018-03-29 The 3% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lot
00303786998890 - Sodium Chloride Inhalation Solution, USP 10% 15mL2018-03-29 The 10% solutions are contained in a 15mL polyethylene vial. The vials have a tear-off top and a lower tab for displaying the lo

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