Duns Number:196880520
Device Description: BED PAD,45DAY,6 PACK,BSM-1W-6
Catalog Number
-
Brand Name
BED PAD,45DAY,6 PACK,BSM-1W-6
Version/Model Number
95080
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
Yes
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
1d098685-859a-4230-bc9f-e92bc23d594c
Public Version Date
July 29, 2021
Public Version Number
2
DI Record Publish Date
July 15, 2021
Package DI Number
10840948101295
Quantity per Package
6
Contains DI Package
00840948101298
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 51 |
2 | A medical device with a moderate to high risk that requires special controls. | 94 |