Duns Number:054318779
Device Description: Optional Cuff (9" to 17") for Omron Digital Blood Pressure Monitor
Catalog Number
HEM-RML31-B
Brand Name
Omron Wide Range D-ring Cuff
Version/Model Number
HEM-RML31-B
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182579,K182579
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
8b9f3ccc-9cef-4afa-9ff4-33cdb999e9d9
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
April 03, 2019
Package DI Number
10073796341722
Quantity per Package
20
Contains DI Package
00073796341725
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |