Duns Number:025460908
Device Description: COVER,PROBE,TEMPLE THERMOMETER,CASE
Catalog Number
MDS9699CS
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS9699CS
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"
Yes
For Single-Use
Yes
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
ed39dca3-2c82-42b1-8de8-f147fb641456
Public Version Date
January 04, 2021
Public Version Number
1
DI Record Publish Date
December 25, 2020
Package DI Number
30080196921069
Quantity per Package
250
Contains DI Package
10080196921065
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |