AccessGUDID - DEVICE: Para-Pak 10% Formalin Fixative (00840733101908)

GUDID

Device Identifier (DI) Information

Brand Name: Para-Pak 10% Formalin Fixative
Version or Model: 900412
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 900412
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733101908
Issuing Agency: GS1
Commercial Distribution End Date: May 19, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transportation.

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):	Yes
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?
57911	Faecal specimen container IVD, transport buffer/medium	A covered receptacle containing transport buffer solution or microbiological medium (e.g., Carey-Blair transport medium) intended to be used for the collection, preservation, and transport of a faecal specimen for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IGG	Formaldehyde (Formalin, Formol)

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: bbbbba2d-9a14-4fd9-9145-05610a175405
Public Version Date: July 22, 2021
Public Version Number: 3
DI Record Publish Date: December 09, 2020