DEVICE: HUDSON RCI (04026704597024)
Device Identifier (DI) Information
HUDSON RCI
IPN040271
In Commercial Distribution
003-01
TELEFLEX INCORPORATED
IPN040271
In Commercial Distribution
003-01
TELEFLEX INCORPORATED
AQUAPAK Sterile Water
Device Characteristics
MR Unsafe | |
No | |
No | |
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? |
---|---|---|---|---|
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTT | HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141353 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
99c6a61e-0674-4dfa-8169-70998b5ed853
November 14, 2019
5
September 16, 2016
November 14, 2019
5
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 |
---|---|---|---|---|---|
24026704597028 | 20 | 04026704597024 | 2019-09-30 | Not in Commercial Distribution | Case |
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