Duns Number:074574094
Device Description: Aneroid Sphygmomanometer, adult size. A device designed to measure blood pressure consist Aneroid Sphygmomanometer, adult size. A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb(arm or thigh), an inflation bulb for controlling the air pressure within the cuff, and aneroid manometer, and tubing.
Catalog Number
92073.
Brand Name
Think Medical
Version/Model Number
92073
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 18, 2022
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"
-
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
K081951
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
55cacce3-cacb-4110-aa3a-bc0890379e16
Public Version Date
April 18, 2022
Public Version Number
2
DI Record Publish Date
April 05, 2022
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. | 1 |