Duns Number:025460908
Device Description: SET, BP, CUFF, BLD, PVC, 1T, INF
Catalog Number
MDS91412
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS91412
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
K090014
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
7ec2d82b-32fd-4b4b-9fe4-4984b87fe467
Public Version Date
December 03, 2020
Public Version Number
1
DI Record Publish Date
November 25, 2020
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 |