DEVICE: Blender Unit E type (04942962609920)
Device Identifier (DI) Information
Blender Unit E type
60992
In Commercial Distribution
60992
ATOM MEDICAL CORPORATION
60992
In Commercial Distribution
60992
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? |
---|---|---|---|---|
44225 | Oxygen/air breathing gas mixer, hospital |
An independent mechanical device designed for accurate mixing of air and oxygen (O2) with O2 concentrations ranging from 21% to 100% (oxygen/air proportioner) that are appropriated for breathing in patients who need a concentration of O2 above the normal concentration in air. The mixer receives air and oxygen from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, oxygen tents, and/or masks.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZR | Mixer, Breathing Gases, Anesthesia Inhalation |
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 |
---|
Width: 200 Millimeter |
Height: 370 Millimeter |
Device Record Status
3f8c43a7-1f1a-4f15-aec2-b1d1d2b7c939
January 29, 2019
3
September 08, 2015
January 29, 2019
3
September 08, 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 |
---|---|---|---|---|---|
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