Duns Number:025460908
Device Description: CUFF, BP, REUSE, 2T, LRG AD, BV
Catalog Number
MDS9914BVRE
Brand Name
Medline
Version/Model Number
MDS9914BVRE
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
3abf9b08-e01f-4d45-b34b-35a9b66a2e79
Public Version Date
February 16, 2021
Public Version Number
1
DI Record Publish Date
February 08, 2021
Package DI Number
20888277663364
Quantity per Package
5
Contains DI Package
10888277663367
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| 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 |