Duns Number:006959555
Device Description: Meijer Instant Ear Thermometer, Childrens
Catalog Number
4551494
Brand Name
Meijer
Version/Model Number
74-340CH
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)
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
7ba10d84-5500-4129-b4ec-307a25eee3b1
Public Version Date
December 11, 2020
Public Version Number
1
DI Record Publish Date
December 03, 2020
Package DI Number
30719283834554
Quantity per Package
4
Contains DI Package
00719283834553
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 45 |
U | Unclassified | 1 |