Duns Number:002348191
Device Description: LMA® Guardian Cuff Pilot™ Size 4
Catalog Number
1C5040
Brand Name
LMA AIRWAY MANAGEMENT
Version/Model Number
IPN047071
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
0e37e803-52ec-4aed-bdc2-26f1f2107817
Public Version Date
September 10, 2019
Public Version Number
2
DI Record Publish Date
September 21, 2018
Package DI Number
55060112313917
Quantity per Package
27
Contains DI Package
25060112313916
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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 |