Duns Number:198227881
Device Description: Welch Allyn Green Series 777 Integrated Wall System for Connex® Spot Monitor (CSM) or Spot Welch Allyn Green Series 777 Integrated Wall System for Connex® Spot Monitor (CSM) or Spot Vital Signs 4400 Device (Spot) with PanOptic Basic LED Ophthalmoscope, MacroView Basic LED Otoscope, and Ear Specula Dispenser (CSM and Spot sold separately)
Catalog Number
777-PM2WCX-US
Brand Name
Welch Allyn, Inc.
Version/Model Number
901027
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
HLI
Product Code Name
Ophthalmoscope, ac-powered
Public Device Record Key
44b8b393-9397-47bd-8334-e5b125dd4798
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 2022
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 |