Duns Number:198227881
Device Description: 767 Integrated Diagnostic System with 76720 Wall Transformer with Clock, 76751 SureTemp 767 Integrated Diagnostic System with 76720 Wall Transformer with Clock, 76751 SureTemp Thermometer, 767 Tycos Wall Aneroid and 52401 KleenSpec Plus Dispenser
Catalog Number
76720-TAKX
Brand Name
Welch Allyn, Inc.
Version/Model Number
901027
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 24, 2017
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
HMF
Product Code Name
Stand, instrument, ac-powered, ophthalmic
Public Device Record Key
63a539ae-b044-4f77-99d0-1bc2d1b4145a
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
September 17, 2016
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 |