The Para-Pak system is a convenient system for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites / bacterial pathogens. It is designed for easy collection of specimens by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transportation.

The Para
Para-Pak EcoFix / C&S / Clean - 331312

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LDX

Device Name: Fixative, Metallic Containing

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: PA

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.4010

Third Party Flag: N

Medical Specialty: PA

Code: JSM

Device Name: Culture Media, Non-Propagating Transport

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.2390

Third Party Flag: Y

Medical Specialty: MI

Code: FMH

Device Name: Container, Specimen, Sterile

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.3250

Third Party Flag: N

Medical Specialty: PA

Device Id: 00840733103124

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A