Duns Number:062028220
Device Description: 2-TUBE SINGLE PATIENT USE CUFF YELLOW ADULT
Catalog Number
06-270-131
Brand Name
MABIS
Version/Model Number
06-270-131
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"
-
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
K082542,K082542
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
29b42dcf-d607-4f2c-a5af-84ee7fb55432
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 11, 2017
Package DI Number
10767056060156
Quantity per Package
30
Contains DI Package
00767056060159
Package Discontinue Date
-
Package Status
-
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 206 |