Duns Number:006959555
Device Description: Meijer Baby 9-Second Flexible Tip Digital Thermometer
Catalog Number
-
Brand Name
Meijer
Version/Model Number
74-359B
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
K041516,K041516,K041516
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
af329e9f-501c-458d-a566-b8aa43e8b6b1
Public Version Date
December 11, 2020
Public Version Number
1
DI Record Publish Date
December 03, 2020
Package DI Number
30713733166998
Quantity per Package
6
Contains DI Package
00713733166997
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate
| 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 |