Duns Number:198227881
Device Description: Welch Allyn SureTemp Plus 690 Wall-Mount Electronic Thermometer (One per Room) with 4-6 Se Welch Allyn SureTemp Plus 690 Wall-Mount Electronic Thermometer (One per Room) with 4-6 Second Oral, 10-13 Second Rectal and Pediatric Axillary, and 12-15 Second Adult Axillary Temperature Readings in Fahrenheit or Celsius; Interchangeable Rectal Probe Well, Rectal Probe with 9.0 ft/2.7 m Cord, Last Temperature Recall; 3 Alkaline AA Batteries
Catalog Number
01690-300M
Brand Name
Welch Allyn, Inc.
Version/Model Number
901053
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 07, 2016
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
7f31af71-31b3-4da1-9612-01ec19b06848
Public Version Date
October 19, 2020
Public Version Number
4
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 |