Duns Number:316153865
Device Description: Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood mo Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood monitoring unit BMU 40 is used to monitor the patient’s key blood levels during extracorporeal circulation. On the basis of the blood levels, the user can immediately adjust the settings of the equipment being used, thereby increasing patient safety.
Catalog Number
70104.5532
Brand Name
BMU 40
Version/Model Number
Y-Datacable kit (Lemo auf 2 x DE9f)
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
K090147
Product Code
DRY
Product Code Name
MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
Public Device Record Key
daf23ddc-1c80-4643-8ff8-413eb41f98b6
Public Version Date
September 28, 2021
Public Version Number
4
DI Record Publish Date
March 13, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |