DEVICE: JITTO (04710810119880)
Device Identifier (DI) Information
JITTO
GB20
In Commercial Distribution
GiO Digital Pressure Gauge, 0~80cmH O
GALEMED CORPORATION
GB20
In Commercial Distribution
GiO Digital Pressure Gauge, 0~80cmH O
GALEMED CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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36289 | Transport electric ventilator |
An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.
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FDA Product Code
[?]Product Code | Product Code Name |
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CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K122627 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
921909bb-f64f-4a63-8cef-f82964b2e510
July 06, 2018
3
October 15, 2015
July 06, 2018
3
October 15, 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 |
---|---|---|---|---|---|
44710810119888 | 4 | 24710810119884 | In Commercial Distribution | Carton | |
24710810119884 | 10 | 04710810119880 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined