Duns Number:401966697
Catalog Number
-
Brand Name
CARESCAPE
Version/Model Number
Monitor B450-LI
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K132533
Product Code
BZL
Product Code Name
COMPUTER, OXYGEN-UPTAKE
Public Device Record Key
51aa05e0-2152-44d6-86a8-0faaeef126e3
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
July 22, 2016
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 | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 224 |