Duns Number:002348191
Device Description: Laryngeal Mask Airway
Catalog Number
1D2040
Brand Name
LMA AIRWAY MANAGEMENT
Version/Model Number
IPN923208
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAE
Product Code Name
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
Public Device Record Key
c5235316-1c4b-42e8-be3c-40ccc637ed87
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
Package DI Number
25060112318881
Quantity per Package
10
Contains DI Package
15060112318884
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |