DEVICE: Resp-O2 Oral Airways, Berman Type (00840117316010)
Device Identifier (DI) Information
Resp-O2 Oral Airways, Berman Type
36312
In Commercial Distribution
Dynarex Corporation
36312
In Commercial Distribution
Dynarex Corporation
Each Kit Contains: 1-Infant (40 mm), 1-Child (60 mm),1-Small Adult (80 mm),1-Medium Adult (90 mm),1-Large Adult (100 mm),1-XL Adult (110 mm)
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? |
---|---|---|---|---|
42424 | Oropharyngeal airway, single-use |
A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAE | Airway, Oropharyngeal, Anesthesiology |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9ed3de60-5563-4f10-8a19-cad5a2202549
May 22, 2025
4
April 22, 2021
May 22, 2025
4
April 22, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00840117315884 | 6 | 00840117316010 | In Commercial Distribution | Box | |
00840117336216 | 20 | 00840117315884 | In Commercial Distribution | Shipper |
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
[?]
No Customer Contact currently defined