Duns Number:557821760
Device Description: The Blood Collection Monitor CM350 is a blood collection device to measure blood volume co The Blood Collection Monitor CM350 is a blood collection device to measure blood volume collected in the blood bag, and clamps the tubing automatically when the collected blood volume reaches the preset target volume. The device is powered by a rechargeable battery.
Catalog Number
CM350
Brand Name
Blood Collection Monitor CM350
Version/Model Number
CM350
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KSQ
Product Code Name
Device, Blood Mixing And Blood Weighing
Public Device Record Key
21072e4e-394f-408b-bc1d-5a0de9fd7b97
Public Version Date
April 27, 2020
Public Version Number
1
DI Record Publish Date
April 17, 2020
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 | 10 |