Duns Number:527971025
Device Description: DECG reusable legplate adapter cable for GE Compatible, 9898 031 37801, rectangle connecto DECG reusable legplate adapter cable for GE Compatible, 9898 031 37801, rectangle connector
Catalog Number
-
Brand Name
Unimed
Version/Model Number
10434
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112544
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
97710d48-69fe-46ec-8c18-01408b5c7f21
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9415 |