Duns Number:025460908
Device Description: DBD-MONITOR, BP, AUTO, DIGITAL, ADULT
Catalog Number
MDS1001CS
Brand Name
Medline
Version/Model Number
MDS1001CS
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K153552,K153552
Product Code
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
2dc61473-6bcc-4157-862f-306adde35546
Public Version Date
December 14, 2020
Public Version Number
1
DI Record Publish Date
December 04, 2020
Package DI Number
00888277720346
Quantity per Package
36
Contains DI Package
00888277629656
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 |