Duns Number:054318779
Device Description: 3 Series upper arm blood pressure monitor with 14 memory storage and wide range cuff. Ea 3 Series upper arm blood pressure monitor with 14 memory storage and wide range cuff. Easy one-touch operation.
Catalog Number
BP7100CAN
Brand Name
Omron 3 Series Upper Arm Blood Pressure Monitor
Version/Model Number
BP7100CAN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K133379,K133379
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
4bfeb9a2-f37f-4ca7-a87f-f43443220bcd
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
July 08, 2019
Package DI Number
10073796100312
Quantity per Package
10
Contains DI Package
00073796100315
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 |