DEVICE: Sodium Chloride Inhalation Solution, USP, 0.9%-3mL (00370756661993)
Device Identifier (DI) Information
Sodium Chloride Inhalation Solution, USP, 0.9%-3mL
3mL
In Commercial Distribution
LIFESTAR PHARMA LLC
3mL
In Commercial Distribution
LIFESTAR PHARMA LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44746 | Inhalation therapy saline solution, isotonic |
A sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the respiratory tract of the patient. It is intended to be used with a nebulizer to increase the humidity of respired air through the addition of atomized water to room air or to the gas stream of a breathing circuit. The solution is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the nebulizer. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAF | Nebulizer (Direct Patient Interface) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K232523 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6aa28563-f46d-4146-9f30-6ca674bb7aec
May 07, 2024
1
April 29, 2024
May 07, 2024
1
April 29, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00370756661139
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-888-995-4337
ProductComplaintLifestar@mankindpharma.com
ProductComplaintLifestar@mankindpharma.com