Duns Number:025460908
Device Description: 45 DAY BED SENSOR PAD FOR MDT8201
Catalog Number
MDT82145B6
Brand Name
Medline
Version/Model Number
MDT82145B6
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"
Yes
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
319dd9d0-7a17-453b-a7ad-74fbbdd58af0
Public Version Date
February 25, 2022
Public Version Number
1
DI Record Publish Date
February 17, 2022
Package DI Number
40888277328991
Quantity per Package
6
Contains DI Package
10888277328990
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |