DEVICE: Resusci Flow w/Blender/Rail mounting type (04942962603638)
Device Identifier (DI) Information
Resusci Flow w/Blender/Rail mounting type
60363
In Commercial Distribution
60363
ATOM MEDICAL CORPORATION
60363
In Commercial Distribution
60363
ATOM MEDICAL CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
37498 | Respiratory oxygen therapy system |
An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTL | Ventilator, Emergency, Powered (Resuscitator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 18 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 277 Millimeter |
Width: 185 Millimeter |
Device Record Status
952765a0-89ad-435e-a458-b6bb5b2be012
July 12, 2019
4
September 21, 2016
July 12, 2019
4
September 21, 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
[?]
+81 488533661
hitoshi.hayashi@atomed.co.jp
hitoshi.hayashi@atomed.co.jp