AccessGUDID - DEVICE: ParaCon (00819398026314)

GUDID

Device Identifier (DI) Information

Brand Name: ParaCon
Version or Model: PK1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PK1000
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398026314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: ParaCon™ Filter Funnel, 1000 per case Funnel device that provides a standard and consistent mesh size and allows filtration of fecal material without clogging.

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?
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	Culture Media, Non-Selective And Non-Differential

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 Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b67ed815-c44d-45d7-af96-636454ea1e11
Public Version Date: June 12, 2020
Public Version Number: 1
DI Record Publish Date: June 04, 2020