Duns Number:005192885
Device Description: 3.3FT HS ASM DF*PF VAC US COND
Catalog Number
HS-CS-MN-02013
Brand Name
Ohio
Version/Model Number
HS-CS-MN-02013
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
BYX
Product Code Name
TUBING, PRESSURE AND ACCESSORIES
Public Device Record Key
3549048e-17fe-4a30-84d3-69a5dc21d5a1
Public Version Date
July 18, 2022
Public Version Number
1
DI Record Publish Date
July 10, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6453 |
2 | A medical device with a moderate to high risk that requires special controls. | 208 |