AccessGUDID - DEVICE: Corowell COVID-19 Symptom Screening Test (04260698980015)

GUDID

Device Identifier (DI) Information

Brand Name: Corowell COVID-19 Symptom Screening Test
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001
Company Name: MKG Consulting UG (haftungsbeschränkt)

Primary DI Number: 04260698980015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314278450 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRK	Kit, Test, Olfactory

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee48a58b-6cb2-4246-b323-b10704b9bf67
Public Version Date: August 12, 2021
Public Version Number: 2
DI Record Publish Date: July 01, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14260698980012	125	04260698980015		In Commercial Distribution	box
24260698980019	20	14260698980012		In Commercial Distribution	carton
34260698980016	40	24260698980019		In Commercial Distribution	pallet
04260698980022	10	04260698980015		In Commercial Distribution	pack
14260698980029	100	04260698980022		In Commercial Distribution	carton
24260698980026	90	14260698980029		In Commercial Distribution	pallet
04260698980046	3	04260698980015	2021-08-11	Not in Commercial Distribution	pack
04260698980053	5	04260698980015	2021-08-11	Not in Commercial Distribution	pack