Duns Number:632707092
Catalog Number
-
Brand Name
NIV Mask (M) reuse,2 ports,MAQUET
Version/Model Number
6694585
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2019
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
-
Product Code
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
bca37950-1329-41ed-915f-36c0d62e9eb2
Public Version Date
September 11, 2019
Public Version Number
3
DI Record Publish Date
November 27, 2015
Package DI Number
17325710002091
Quantity per Package
10
Contains DI Package
07325710002094
Package Discontinue Date
September 10, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 62 |
2 | A medical device with a moderate to high risk that requires special controls. | 131 |