AccessGUDID - DEVICE: HardyDisk™ (00816576028320)

GUDID

Device Identifier (DI) Information

Brand Name: HardyDisk™
Version or Model: Z7031
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z7031
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576028320
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: X Factor, HardyDisk™, Hemin disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 each Contains Hemin (X factor) for the speciation of Haemophilus.

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):	No
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?
43513	X factor differentiation disc IVD	One or multiple diagnostic discs impregnated with iron protoporphyrin or X factor, intended to be used in microbial testing for differentiation of the Haemophilus group of bacteria isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

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 -20 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 627132c6-8d35-4b8e-9961-1c212f18e05a
Public Version Date: August 17, 2020
Public Version Number: 1
DI Record Publish Date: August 07, 2020