Duns Number:796452311
Device Description: BC300, BAT, RESET, NC, VOL, STAT LED, DELAY, PAUSE, CORDED ONLY, 2YR WAR
Catalog Number
27720
Brand Name
CORDED BED&CHAIR ALARM W/BATT
Version/Model Number
CSM-BC300
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
KMI
Product Code Name
Monitor, Bed Patient
Public Device Record Key
d5a0698a-791d-406f-8d39-0a03aa0945c0
Public Version Date
May 11, 2022
Public Version Number
1
DI Record Publish Date
May 03, 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 | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |