Duns Number:041674552
Device Description: Chemetron Adapter
Catalog Number
-
Brand Name
MedSource Oxygen Adapter
Version/Model Number
MS-28410
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
CAN
Product Code Name
Regulator, Pressure, Gas Cylinder
Public Device Record Key
e491e9a7-adfd-410c-ab63-8f4af35b20d1
Public Version Date
June 09, 2021
Public Version Number
1
DI Record Publish Date
June 01, 2021
Package DI Number
00840155408821
Quantity per Package
5
Contains DI Package
00840155408814
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |