Duns Number:198227881
Device Description: Welch Allyn Handheld RetinaVue 100 Imager with Charging Dock, Reusable Eye Cup, USB Cable, Welch Allyn Handheld RetinaVue 100 Imager with Charging Dock, Reusable Eye Cup, USB Cable, and 1 Year Partners in Care Comprehensive Program; Lithium-Ion 3.6V Battery. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
Catalog Number
RV100-B
Brand Name
Welch Allyn, Inc.
Version/Model Number
901103
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
PJZ
Product Code Name
Camera, ophthalmic, general-use
Public Device Record Key
17cde03c-0cb3-4da1-a36b-bdf3b6cd79ea
Public Version Date
October 08, 2019
Public Version Number
1
DI Record Publish Date
September 30, 2019
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 |