Innocor

GUDID 05713867000056

Cardio-pulmonary function test & analysis equipment

Innovision ApS

Pulmonary function analysis system, adult

• Primary Device ID: 05713867000056
• NIH Device Record Key: 8e0a53f3-1d99-43ac-a33c-0d697981cb5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innocor
• Version Model Number: INN00400
• Company DUNS: 305276496
• Company Name: Innovision ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713867000056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051907

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-09
• Device Publish Date: 2016-09-01

On-Brand Devices [Innocor]

• 05713867000193: Innocor cardio-pulmonary function test equipment
• 05713867000186: Innocor cardio-pulmonary function test equipment
• 05713867000179: Innocor cardio-pulmonary function test equipment
• 05713867000162: Innocor cardio-pulmonary function test equipment
• 05713867000155: Innocor cardio-pulmonary function test equipment
• 05713867000148: Innocor cardio-pulmonary function test equipment
• 05713867000124: Innocor Cardio-pulmonary function test equipment
• 05713867000100: Innocor Cardio-pulmonary function test equipment
• 05713867000063: Cardio-pulmonary function test & analysis equipment
• 05713867000056: Cardio-pulmonary function test & analysis equipment
• 05713867000025: Cardio-pulmonary function test & analysis equipment
• 05713867000018: Cardio-pulmonary function test & analysis equipment
• 05713867000001: Innocor Cardio-pulmonary function test equipment