Mask, surgical, single use

Public Summary

Summary for ARTG Entry:

339247

Pakshir Medical Pty Ltd - Mask, surgical, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Pakshir Medical Pty Ltd

Postal Address

U 2307 7 Riverside Quay, Southbank, VIC, 3006

Australia

ARTG Start Date

9/07/2020

Product Category

Medical Device Class 1

Status

Active

Approval Area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2

(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for

relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;

and civil penalties may apply.

Manufacturers

Name

Address

Shanghai Jianzhong Medical Packaging

Company Limited

Building 16 No 789 Puxing Road Pujiang Town

Shanghai, ,

China

Products

1 . Mask, surgical, single use

Product Type

Single Device Product

Effective Date

9/07/2020

GMDN

35177 Mask, surgical, single use

Intended Purpose

Disposable 3 Ply Face Mask with Earloop general purpose for protection against droplets, bodily fluids etc; Provides barrier

protection to prevent the transmission of airborne organisms.

Specific Conditions

No Specific Conditions included on Record

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Public Summary

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Produced at 22.07.2020 at 10:10:18 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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