Duns Number:207372814
Device Description: Large easy to read screen• Multi-user (4 x 30 memories)• Heart rate indicator• Date and t Large easy to read screen• Multi-user (4 x 30 memories)• Heart rate indicator• Date and time indicator• Large cuff size is available (#106-931) Meets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International Protocol Includes: Blood pressure monitor and medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference Requires 4 AA batteries (not included)
Catalog Number
-
Brand Name
Physiologic essentiA Blood Pressure Monitor
Version/Model Number
106-930
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"
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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
705baf2b-aeb5-4b6c-bc7e-12ffb3b0be4a
Public Version Date
October 07, 2021
Public Version Number
6
DI Record Publish Date
September 26, 2016
Package DI Number
05756599154062
Quantity per Package
12
Contains DI Package
00057565069362
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 |