Duns Number:062028220
Device Description: EXTENSION TUBE FOR 40-370-000
Catalog Number
40-275-000
Brand Name
MABIS
Version/Model Number
40-275-000
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"
-
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
K002831,K002831
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
0f0611e7-9e76-4049-8665-98517bc80476
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10767056402758
Quantity per Package
50
Contains DI Package
00767056402751
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 206 |