Duns Number:177939027
Device Description: MEDLINE CUFF, BP, DIS, 1T, SM ADL, HP
Catalog Number
-
Brand Name
Medline
Version/Model Number
MDS9912HP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 21, 2019
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"
-
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
K032821,K032821
Product Code
NPP
Product Code Name
Reprocessed Blood Pressure Cuff
Public Device Record Key
d594bbe6-97f4-4498-b917-70f644e09c7b
Public Version Date
March 19, 2021
Public Version Number
4
DI Record Publish Date
February 04, 2017
Package DI Number
30817357022231
Quantity per Package
20
Contains DI Package
10817357022237
Package Discontinue Date
March 19, 2021
Package Status
Not 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |