DEVICE: HUDSON RCI (04026704596553)
Device Identifier (DI) Information
HUDSON RCI
IPN044944
In Commercial Distribution
5383
TELEFLEX INCORPORATED
IPN044944
In Commercial Distribution
5383
TELEFLEX INCORPORATED
DISPOSABLE PEEP VALVE W/22MM OD CONNECT.
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? |
---|---|---|---|---|
46823 | PEEP valve, single-use |
A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTM | Ventilator, emergency, manual (resuscitator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K964719 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Special Storage Condition, Specify: Store in clean dry conditions away from heat and light. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: PEEP Valve |
Device Record Status
3071157d-bd77-49e3-9f36-5fa792488d7a
August 28, 2018
6
October 16, 2015
August 28, 2018
6
October 16, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
24026704596557 | 10 | 04026704596553 | 2018-08-27 | Not in Commercial Distribution | Box |
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