Duns Number:126646582
Device Description: A hand-held battery powered, electronic instrument designed for oral, underarm or rectal u A hand-held battery powered, electronic instrument designed for oral, underarm or rectal use to measure a patient's body temperature. The device has a flexible tip and an LDC display. It is designed to take a temperature reading in approximately 10 seconds. This is a reusable device.
Catalog Number
-
Brand Name
RITE AID
Version/Model Number
KD-2090BABY.RA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 2019
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
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
ee0d8de2-88f7-4d64-bda9-aae9ab79ac22
Public Version Date
July 04, 2019
Public Version Number
2
DI Record Publish Date
March 17, 2018
Package DI Number
40011822610696
Quantity per Package
8
Contains DI Package
20011822610692
Package Discontinue Date
July 03, 2019
Package Status
Not 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. | 19 |