Duns Number:198227881
Device Description: Welch Allyn SureTemp Plus 692 Handheld Electronic Thermometer; Device Only; 3 Alkaline AA Welch Allyn SureTemp Plus 692 Handheld Electronic Thermometer; Device Only; 3 Alkaline AA Batteries; Multiple Language
Catalog Number
01692-100
Brand Name
Welch Allyn, Inc.
Version/Model Number
901053
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)
Yes
Over the Counter (OTC)
-
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
757b02b2-3d27-4540-85ad-a4543389fff3
Public Version Date
June 28, 2022
Public Version Number
6
DI Record Publish Date
December 05, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |