← Back to catalogue

Innovision

FDA UDI

Class II (US FDA UDI)

by Innovere Medical, Inc.

Identity

Trade Name
Innovision FDA UDI
Generic Name
Patient audiovisual communication/entertainment system FDA UDI
Device Name
Innovision Audio FDA UDI
Model / Reference
00 FDA UDI
Description
Innovision Audio FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00628176432212 FDA UDI
510(k) Number
K193218 FDA UDI
FDA Product Code
LNH FDA UDI
GMDN Term
Patient audiovisual communication/entertainment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Patient audiovisual communication/entertainment system

Innovision by Innovere Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient audiovisual communication/entertainment system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Innovere Medical, Inc.

Sources (1)

  • FDA UDI 3df011ba-5a6c-4e19-87cf-80d620585e07 35 fields · synced May 30, 2026