Duns Number:038000253
Device Description: 14.5F X 24CM Hemo-Flow® FULL SET (CUFF 19CM FROM TIP)
Catalog Number
RMS29401
Brand Name
Hemo-Flow®
Version/Model Number
RMS29401
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 28, 2021
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"
Yes
For Single-Use
Yes
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
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
40bc5c3c-fff4-4c03-92cf-a587ffa322e0
Public Version Date
June 23, 2021
Public Version Number
3
DI Record Publish Date
November 26, 2020
Package DI Number
50884908158125
Quantity per Package
5
Contains DI Package
00884908158120
Package Discontinue Date
May 28, 2021
Package Status
Not 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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |