AccessGUDID - DEVICE: Para-Pak Zn-PVA/Ultra 10% Formalin (00840733103148)

GUDID

Device Identifier (DI) Information

Brand Name: Para-Pak Zn-PVA/Ultra 10% Formalin
Version or Model: 381012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 381012
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733103148
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: Para-Pak 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 those not trained in microbiological procedures and afford and excellent means of minimizing the adverse effects of delay in specimen transport.

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?
57910	Faecal specimen container IVD, fixative	A covered plastic receptacle containing a fixative solution [e.g., sodium acetate, acetic acid and/or formaldehyde (SAF), Schaudinn’s, polyvinyl alcohol (PVA) or acid alcohol] intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of intestinal parasites and/or their eggs (ova)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDX	Fixative, Metallic Containing
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: ecb004d3-7e59-4082-88c2-73676e8a5657
Public Version Date: July 01, 2024
Public Version Number: 3
DI Record Publish Date: December 10, 2020