Duns Number:656103819
Device Description: INDEX™ tubeless blood pressure monitor.
Catalog Number
-
Brand Name
GARMIN
Version/Model Number
BP707
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2022
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
897803cd-6660-43c5-92aa-12f0121c6a63
Public Version Date
September 28, 2022
Public Version Number
1
DI Record Publish Date
September 20, 2022
Package DI Number
14719873310071
Quantity per Package
12
Contains DI Package
04719873310074
Package Discontinue Date
September 20, 2022
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |