Duns Number:065183758
Device Description: ARC Ready For Baby Kit
Catalog Number
Y7825A1
Brand Name
American Red Cross
Version/Model Number
Y7825
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
28f958b8-9653-454e-81bc-b705013d9d7b
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
November 04, 2019
Package DI Number
B268Y78251
Quantity per Package
1
Contains DI Package
B268Y78251
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Package
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |