Pasture F550G Respirator

Basic Information

• Brand Name: Pasture F550G Respirator
• Primary DI: B624F550G200
• Version / Model: F550G
• Company Name: PASTURE PHARMA PTE LTD
• Labeler DUNS: 628369480
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-01-03
• Public Version: 5
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: d25ed0dc-1bfb-4499-b1c8-78e6865135b9

Device Description

This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZJ	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies	General Hospital	880.6260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57793	Public respirator, single-use	A form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large and small particles when considered necessary (e.g., viral epidemic). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B624F550G200	HIBCC
Unit of Use	B624A550G0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K083176	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 50 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 50 Degrees Celsius