Duns Number:054318779
Device Description: Omron Digital Weight Scale Telehealth with Bluetooth - 20-550 lbs.
Catalog Number
HN-290T
Brand Name
Omron Digital Weight Scale
Version/Model Number
HN-290T
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRI
Product Code Name
Scale, Stand-On, Patient
Public Device Record Key
38b93015-e8a7-47cd-bad9-558b10325488
Public Version Date
February 09, 2021
Public Version Number
1
DI Record Publish Date
February 01, 2021
Package DI Number
10073796842908
Quantity per Package
3
Contains DI Package
00073796842901
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |