Corowell COVID-19 Symptom Screening Test 001

GUDID 14260698980012

The Corowell COVID-19 Symptom Screening Test is intended to objectively testing of the sense of smell. It enables the identification of subjects whose olfactory perception is deviating, restricted or newly got lost. The Corowell COVID-19 Symptom Screening Test is a device for home use. The Corowell COVID-19 Symptom Screening Test can be performed self-administered by the subject. The target population is adults over 18 years of age.

MKG Consulting UG (haftungsbeschränkt)

Olfactory test stick

• Primary Device ID: 14260698980012
• NIH Device Record Key: ee48a58b-6cb2-4246-b323-b10704b9bf67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corowell COVID-19 Symptom Screening Test
• Version Model Number: 1
• Catalog Number: 001
• Company DUNS: 314278450
• Company Name: MKG Consulting UG (haftungsbeschränkt)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com
• Phone: +49264190828
• Email: info@corowell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260698980015 [Primary]
GS1	04260698980022 [Package]; Contains: 04260698980015; Package: pack [10 Units]; In Commercial Distribution
GS1	04260698980046 [Package]; Contains: 04260698980015; Package: pack [3 Units]; Discontinued: 2021-08-11; Not in Commercial Distribution
GS1	04260698980053 [Package]; Contains: 04260698980015; Package: pack [5 Units]; Discontinued: 2021-08-11; Not in Commercial Distribution
GS1	14260698980012 [Package]; Contains: 04260698980015; Package: box [125 Units]; In Commercial Distribution
GS1	14260698980029 [Package]; Contains: 04260698980022; Package: carton [100 Units]; In Commercial Distribution
GS1	24260698980019 [Package]; Package: carton [20 Units]; In Commercial Distribution
GS1	24260698980026 [Package]; Contains: 14260698980029; Package: pallet [90 Units]; In Commercial Distribution
GS1	34260698980016 [Package]; Contains: 24260698980019; Package: pallet [40 Units]; In Commercial Distribution

FDA Product Code

• NRK: Kit, Test, Olfactory

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01