AccessGUDID - DEVICE: Para-Pak EcoFix (00840733103421)

GUDID

Device Identifier (DI) Information

Brand Name: Para-Pak EcoFix
Version or Model: 9014-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9014-01
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733103421
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: Para-Pak EcoFix is a convenient one-vial system for the routine collection, transportation, preservation, and examination of stool specimens for the intestinal parasites. Both concentration and permanent stain may be performed from EcoFix preserved specimens. The fixative affords 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?
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: 3f74fe3d-0dc1-4472-8a8c-95b775ada986
Public Version Date: November 04, 2021
Public Version Number: 1
DI Record Publish Date: October 27, 2021