Duns Number:632707092
Catalog Number
-
Brand Name
Anest mask reuse,size 1 with MAQUET
Version/Model Number
6694570
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
-
Product Code
BSJ
Product Code Name
Mask, Gas, Anesthetic
Public Device Record Key
956cb3aa-4868-46f3-a510-4adf8f8c6e16
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 30, 2015
Package DI Number
17325710002411
Quantity per Package
10
Contains DI Package
07325710002414
Package Discontinue Date
-
Package Status
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 |