Duns Number:529903321
Catalog Number
-
Brand Name
eufy
Version/Model Number
T9201
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
K134029,K134029,K134029
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
ec8f87d0-3103-4716-a1c7-0298c4be034d
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
April 25, 2017
Package DI Number
16947468555066
Quantity per Package
1
Contains DI Package
06947468555069
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
1pcs/box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |