Corowell COVID-19 Symptom Screening Test

Basic Information

• Brand Name: Corowell COVID-19 Symptom Screening Test
• Primary DI: 04260698980015
• Version / Model: 1
• Catalog Number: 001
• Company Name: MKG Consulting UG (haftungsbeschränkt)
• Labeler DUNS: 314278450
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-01
• Public Version: 2
• Public Version Date: 2021-08-12
• Public Version Status: Update
• Public Device Record Key: ee48a58b-6cb2-4246-b323-b10704b9bf67

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRK	Kit, Test, Olfactory	Ear, Nose, Throat	874.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65154	Olfactory test stick	A non-powered, scented device intended to be used to assess a patient’s olfactory function (normosmia, hyposmia, or anosmia). It typically consists of a scented stick(s) intended to be sniffed by the patient, followed by patient description of smell perception. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14260698980012	GS1	box	125	In Commercial Distribution
Primary	04260698980015	GS1
Package	24260698980019	GS1	carton	20	In Commercial Distribution
Package	34260698980016	GS1	pallet	40	In Commercial Distribution
Package	04260698980022	GS1	pack	10	In Commercial Distribution
Package	14260698980029	GS1	carton	100	In Commercial Distribution
Package	24260698980026	GS1	pallet	90	In Commercial Distribution
Package	04260698980046	GS1	pack	3	Not in Commercial Distribution	2021-08-11
Package	04260698980053	GS1	pack	5	Not in Commercial Distribution	2021-08-11

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius