Duns Number:021437579
Device Description: Digital Baby Lactation Scale, 45lbx0.1oz (20kgx2g) includes ULc approved 100-240 VAC 50/60 Digital Baby Lactation Scale, 45lbx0.1oz (20kgx2g) includes ULc approved 100-240 VAC 50/60Hz adapter
Catalog Number
DS4500
Brand Name
Doran Scales
Version/Model Number
DS4500
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
FRW
Product Code Name
Scale, Patient
Public Device Record Key
5c3490cf-3e48-47a6-a18c-ddcdb7eebd8e
Public Version Date
June 08, 2022
Public Version Number
1
DI Record Publish Date
May 31, 2022
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 | 25 |