Duns Number:025460908
Device Description: CUFF, BP, REUSE, 1T, LG ADL, HP
Catalog Number
MDS9914HPRE
Brand Name
Medline
Version/Model Number
MDS9914HPRE
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)
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
664e70d8-196e-4f4b-904f-f5a48da7f97d
Public Version Date
January 29, 2021
Public Version Number
1
DI Record Publish Date
January 21, 2021
Package DI Number
20888277360362
Quantity per Package
5
Contains DI Package
10888277360365
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
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 |