Duns Number:037289290
Device Description: Antimicrobial High Resolution Digital Neonatal/Pediatric Four Sided Tray Scale with Built- Antimicrobial High Resolution Digital Neonatal/Pediatric Four Sided Tray Scale with Built-In Pelstar Wireless Technology; KG only
Catalog Number
-
Brand Name
Health o meter Professional
Version/Model Number
2210KG4-AM-BT
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
4de9feff-e4af-4a5f-aad4-ad6ef6bf1292
Public Version Date
January 18, 2022
Public Version Number
1
DI Record Publish Date
January 10, 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 | 239 |