Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV

GUDID 00376204300056

Inhalation therapy saline solution, hypertonic

Primary Device ID	00376204300056
NIH Device Record Key	4c39b10d-4afc-41f4-80d0-e893c126ff8d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV
Version Model Number	5 mL
Company DUNS	968062294
Company Name	RITEDOSE PHARMACEUTICALS, LLC
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00376204300056 [Primary]
GS1	00376204300995 [Unit of Use]

CAF	Nebulizer (Direct Patient Interface)

Steralize Prior To Use	false
Device Is Sterile	true

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00376204022958 - Sodium Chloride Inhalation Solution, USP, 3% 4mL UDV	2022-01-19
00376204023955 - Sodium Chloride Inhalation Solution, USP, 10% 4mL UDV	2022-01-19
00376204300018 - Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped	2021-09-07 One vial per foil pouch
00376204300032 - Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV	2018-03-29
00376204300056 - Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV	2018-03-29
00376204300056 - Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV	2018-03-29