Duns Number:081135914
Device Description: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and then release the artery under the cuff in a controlled manner, and a mechanical manometer to measure the pressure.
Catalog Number
-
Brand Name
Paramed
Version/Model Number
Manual Blood Pressure cuff (Blue Color). Comfort Model
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
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
56a1cbc4-d618-40b6-a854-e6731f33c686
Public Version Date
June 18, 2018
Public Version Number
1
DI Record Publish Date
May 18, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |