DEVICE: HUDSON RCI (04026704597192)
Device Identifier (DI) Information
HUDSON RCI
IPN040631
In Commercial Distribution
037-39
TELEFLEX INCORPORATED
IPN040631
In Commercial Distribution
037-39
TELEFLEX INCORPORATED
AQUAPAK 0.9% NaCl for Inhalation 760 mL w/ 028 Nebulizer Adaptor
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OGG | Humidifier nebulizer kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8ae651fd-29a7-4c16-bc07-887f8be7c79c
March 29, 2018
2
September 16, 2016
March 29, 2018
2
September 16, 2016
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(919)544-8000
CS@TELEFLEX.COM
CS@TELEFLEX.COM