DEVICE: Forsure (00815123012829)
Device Identifier (DI) Information
Forsure
11150080
In Commercial Distribution
11150080
FORSURE MEDICAL PRODUCTS LLC
11150080
In Commercial Distribution
11150080
FORSURE MEDICAL PRODUCTS LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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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Special Storage Condition, Specify: STORE IN CLEAN AND DRY CONDITIONS AWAY FROM HEAT AND LIGHT |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 80 MM |
Device Record Status
2ca6f2e9-5f7f-4145-b2e9-ce37922dca32
March 29, 2018
2
February 13, 2018
March 29, 2018
2
February 13, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20815123012823 | 45 | 10815123012826 | In Commercial Distribution | MASTER CASE | |
10815123012826 | 10 | 00815123012829 | In Commercial Distribution | INNER 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
[?]
No Customer Contact currently defined