AccessGUDID - DEVICE: Revogene Mock Pie (00840733102332)

GUDID

Device Identifier (DI) Information

Brand Name: Revogene Mock Pie
Version or Model: 610208
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 610208
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733102332
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene instrument and the Revogene assays. The MOCK Pie simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62346	Centrifuge tube counterbalance	A device in the form of a centrifuge tube intended to balance weight across a centrifuge rotor when processing uneven numbers of tubes or tubes containing different volumes of fluid. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	Real Time Nucleic Acid Amplification System

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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 Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -30 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01068da0-2b69-455e-af4c-30ba6b663165
Public Version Date: July 07, 2020
Public Version Number: 1
DI Record Publish Date: June 29, 2020