AccessGUDID - DEVICE: Para-Pak Ultra SVT (00840733102882)

GUDID

Device Identifier (DI) Information

Brand Name: Para-Pak Ultra SVT
Version or Model: 981612
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 981612
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733102882
Issuing Agency: GS1
Commercial Distribution End Date: September 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: Para-Pak SVT (Single Vial Transport) is a convenient one-vial system for the routine collection, transportation, preservation and examination of stool specimens for intestinal parasites. Stool specimens preserved in Para-Pak SVT can be used for direct examination, concentration, permanent stain and in fecal immunoassays. The fixative affords an 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?
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
LDX	Fixative, Metallic Containing

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 062293c3-64ff-45c7-aff8-f2e3ef2729c7
Public Version Date: May 07, 2024
Public Version Number: 3
DI Record Publish Date: December 09, 2020