Duns Number:002348191
Device Description: LMA Fastrach™ ETT 6.5mm
Catalog Number
131065
Brand Name
LMA
Version/Model Number
IPN042397
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
ccb3a1e2-0808-455e-bf8f-24d108fc2895
Public Version Date
December 16, 2019
Public Version Number
5
DI Record Publish Date
October 16, 2015
Package DI Number
15060112310451
Quantity per Package
10
Contains DI Package
05060112310454
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 |