Duns Number:002348191
Device Description: LMA Fastrach™ ETT 7.5mm
Catalog Number
131075
Brand Name
LMA
Version/Model Number
IPN042400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
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
K991580,K991580,K991580,K991580
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
074c3fd7-35f3-4083-b130-1cc76396ddcd
Public Version Date
January 18, 2021
Public Version Number
7
DI Record Publish Date
October 16, 2015
Package DI Number
25060112310472
Quantity per Package
10
Contains DI Package
15060112310475
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |