Duns Number:079772888
Device Description: A device designed to measure blood pressure consisting of an inflatable cuff that fits aro A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb ( for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid mano bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transm lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may b on a table, or hand held(portable); blood pressure measurement is taken in conjunction with a stethoscope.
Catalog Number
-
Brand Name
My Medic
Version/Model Number
Max0203
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 17, 2021
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)
Yes
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
K190902
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
db6e0ffb-e32c-4114-8025-78fd70c09f67
Public Version Date
July 07, 2021
Public Version Number
2
DI Record Publish Date
January 16, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |