Duns Number:002348191
Device Description: LMA® Unique Evo™ Cuff Pilot™ Size 4
Catalog Number
1D2040
Brand Name
LMA AIRWAY MANAGEMENT
Version/Model Number
IPN047904
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)
Yes
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
0170407c-7f00-4f21-ad50-f96b7ef1b4df
Public Version Date
February 22, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2018
Package DI Number
15060112313971
Quantity per Package
10
Contains DI Package
05060112313974
Package Discontinue Date
February 19, 2021
Package Status
Not 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 |