Duns Number:544332470
Catalog Number
-
Brand Name
shecare
Version/Model Number
HW-F7
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
K173048,K173048,K173048
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
9c65741d-bd19-4e6f-8287-04ee01d22654
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
October 17, 2020
Package DI Number
10810021178353
Quantity per Package
1
Contains DI Package
00810021178349
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |