Duns Number:963223677
Device Description: Travel series BPM. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white Travel series BPM. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white inflate) technology. 399 x 3 users.
Catalog Number
-
Brand Name
Ozeri
Version/Model Number
BP6T
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
dfafd3e1-d1cf-450d-8760-13a3dbad87b6
Public Version Date
September 11, 2020
Public Version Number
1
DI Record Publish Date
September 03, 2020
Package DI Number
10815817013306
Quantity per Package
1
Contains DI Package
00815817013309
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Giftbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |