DEVICE: HUDSON RCI (10193489138443)

Device Identifier (DI) Information

HUDSON RCI
HUD3705
In Commercial Distribution
HUD3705
MEDLINE INDUSTRIES, INC.
10193489138443
GS1

1
025460908 *Terms of Use
AQUAPAK LVN,.45 SALINE,760ML,NO ADAPT
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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.
Active false
44706 Inhalation therapy sterile water
A quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAF Nebulizer (direct patient interface)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141214 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry. Keep away from sunlight. Do not freeze.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d46315d1-d994-4b86-8af2-cbfa289adf33
February 21, 2024
1
February 13, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20193489138440 10 10193489138443 In Commercial Distribution CS
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Secondary DI

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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
+1(800)633-5463
service@medline.com
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