DEVICE: Sodium Chloride Inhalation Solution, USP, 3% 15mL (00303786997893)

Device Identifier (DI) Information

Sodium Chloride Inhalation Solution, USP, 3% 15mL
15mL
In Commercial Distribution

MYLAN PHARMACEUTICALS INC.
00303786997893
GS1

1
059295980 *Terms of Use
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 number and expiration date. One side of the vial has pressure sensitive label and the other side is blank. The vials are supplied in cartons of 50 vials. 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Inhalation therapy saline solution, hypertonic A sterile, hypertonic saline solution, consisting only of water and sodium chloride (> 0.9% NaCl) intended to be used for the induction of sputum in a patient, via physiological osmotic mechanisms, especially indicated for palliative treatment of cystic fibrosis (CF). It is intended to be used with a nebulizer to produce a mist that can be inhaled into the lungs where cells lining the airways are triggered to release water and facilitate restoration of the layer of moisture lining the airways for clearing of mucous. The solution is typically available in a single unit-of-use container. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CAF Nebulizer (Direct Patient Interface)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6b1dc9fb-21c6-4caa-b702-3452f7ef50b0
March 29, 2018
2
December 12, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-877-446-3679
customer.service@mylan.com
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