Duns Number:006959555
Device Description: Meijer 2 Second Flexible Tip Digital Thermometer
Catalog Number
73-363
Brand Name
Meijer
Version/Model Number
74-363
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
K983887,K983887,K983887
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
69581f71-6af9-443b-b6fc-618da3803ece
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
30708820985514
Quantity per Package
4
Contains DI Package
00708820985513
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 |