DEVICE: HUDSON RCI (04026704597604)
Device Identifier (DI) Information
HUDSON RCI
IPN044282
In Commercial Distribution
382-70
TELEFLEX INCORPORATED
IPN044282
In Commercial Distribution
382-70
TELEFLEX INCORPORATED
Standard CONCHA-COLUMN Humidifier Cartridge
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? |
---|---|---|---|---|
12050 | Heated respiratory humidifier |
A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.
|
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 [?] |
---|---|
K760866 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not freeze symbol |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ec274eb2-4ce2-4853-bbc4-87cf1d7d49e0
November 22, 2019
4
September 16, 2016
November 22, 2019
4
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 |
---|---|---|---|---|---|
24026704597608 | 48 | 04026704597604 | 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