Duns Number:002348191
Device Description: LMA Fastrach Size 5
Catalog Number
13150
Brand Name
LMA
Version/Model Number
IPN047996
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K051993,K051993,K051993
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
9525d9d7-5485-45ad-9d88-83ef5e93e3e9
Public Version Date
September 10, 2019
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
25060112311813
Quantity per Package
10
Contains DI Package
05060112311819
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |