Duns Number:025460908
Device Description: THERMOMETER, FOREHEAD, NO TOUCH
Catalog Number
MDSNOTOUCH
Brand Name
Medline
Version/Model Number
MDSNOTOUCH
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
-
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
K122221,K122221
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
327d63ee-bfe5-4701-a955-be334bc53d06
Public Version Date
January 01, 2021
Public Version Number
1
DI Record Publish Date
December 24, 2020
Package DI Number
40888277183996
Quantity per Package
6000
Contains DI Package
00888277637910
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |