Duns Number:025460908
Device Description: STERILE TRACH BRUSH 1/PK
Catalog Number
M199124A
Brand Name
ML-CANADA
Version/Model Number
M199124A
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
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
EPE
Product Code Name
BRUSH, CLEANING, TRACHEAL TUBE
Public Device Record Key
0a8feae0-9d70-44e2-a330-cc1d95501ce2
Public Version Date
January 10, 2022
Public Version Number
1
DI Record Publish Date
January 01, 2022
Package DI Number
40080196466864
Quantity per Package
50
Contains DI Package
10080196466863
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |