Duns Number:537208717
Device Description: Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.
Catalog Number
LF3655-109.002
Brand Name
extension module for ri-former®, big-ben® square adult size velcro cuff, MEDLINE
Version/Model Number
LF3655-109.002
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"
-
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
K972301
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
3bee8fe8-1f98-4129-b1f7-daf9e5b88e31
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |