Duns Number:025460908
Device Description: CUFF,BP,DISP,GREEN,1TB,LRG AD LNG,HP
Catalog Number
MDS9914HPLNG
Brand Name
Medline
Version/Model Number
MDS9914HPLNG
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
K071244,K161035
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
538eff72-0278-4a52-aeef-10b721e27b8f
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 09, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |