Duns Number:201740425
Device Description: Main handheld VivoLink unit for use with second generation Integrity V500 system.The UDI i Main handheld VivoLink unit for use with second generation Integrity V500 system.The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00627908020024A82 Amplitrode: DI 00627908020031A90 VivoAmp: DI 00627908020048B71W Bone Conductor: DI 00627908020055ER-2-800 Insert Earphones: DI 00627908020062ER-3A-800 Insert Earphones: DI 00627908020079ER-3C-800 Insert Earphones: DI 00627908020086H-800 EP Headphones: DI 00627908020093H-801 EP Headphones: DI 00627908020109P81-GP OAE Probe: DI 00627908020116P81-UG OAE Probe: DI 00627908020123Computer: DI 00627908020130
Catalog Number
-
Brand Name
Integrity V500
Version/Model Number
V500
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043396
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
7cfb0431-4736-42ba-b316-0019cc9acd04
Public Version Date
April 21, 2020
Public Version Number
4
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |