Duns Number:207372814
Device Description: This top of the line blood pressure monitor is completely automatic. Once the user is spec This top of the line blood pressure monitor is completely automatic. Once the user is specified, all you have to do is to put on the BP cuff and press the start button. Its large and bright blue screen will insure no straining while reading your systolic, diastolic and pulse results. This blood pressure monitor will also automatically indicate where the user's results are on the 6 level, easy to understand, Hypertension Risk Chart.•Bright easy to read screen•Dual user, 60 memories each•Hypertension Risk Indicator (6 level color classification) •Heart rate indicator / pulse•Date and time indicator•Table top, fully Automatic BP monitor (arm type) •Large screen 2.7 in x 4 in (69 x 102 mm) •Backlight screen when reading is completed •Large, easy to see numbers: 30 mm (Systolic); 20 mm (Diastolic); 9 mm (Pulse) •Inflation/ Deflation icons •Average of Last 3 readings/ results •Irregular Heartbeat detection/ icon•Auto shut off: 3 minutes, if left untouched or forgotten•Low battery indicator insures that users are never without their information/ unable able to take their reading •Carrying bagMeets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International ProtocolIncludes: Blood pressure monitor, medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference, transport bag and instructions. Requires 4 AA batteries (not included) A Large cuff is available (#106-931) (optional) Power adaptor: DC 6V 1000mA AC (#106-933) (not included - optional)
Catalog Number
-
Brand Name
Physiologic LuminA Blood Pressure Monitor
Version/Model Number
106-934
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)
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Device labeled as "Not made with natural rubber latex"
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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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
333281e6-cd65-4fe4-9f00-8454226b2a6f
Public Version Date
August 21, 2020
Public Version Number
5
DI Record Publish Date
September 26, 2016
Package DI Number
05756599581448
Quantity per Package
12
Contains DI Package
00057565968887
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |