Duns Number:078312999
Device Description: Digital monitor intended for use in measuring blood pressure and heartbeat rate with arm c Digital monitor intended for use in measuring blood pressure and heartbeat rate with arm circumfrence range from 22 cm to 45 cm (8 3/4" - 17 1/2"). The device is for indoor use only.
Catalog Number
-
Brand Name
Lark Technologies
Version/Model Number
TMB-2092-G
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)
-
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
b5674ba0-9cc5-4b29-bcd9-dd30ba8e4278
Public Version Date
April 11, 2022
Public Version Number
1
DI Record Publish Date
April 01, 2022
Package DI Number
00860008199119
Quantity per Package
10
Contains DI Package
00860008199102
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |