Pasture A520G Respirator

GUDID B624A520G200

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

PASTURE PHARMA PTE LTD

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• Primary Device ID: B624A520G200
• NIH Device Record Key: ecd52e43-9caa-444a-9dd0-4ccfbca7c71a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pasture A520G Respirator
• Version Model Number: A520G
• Company DUNS: 628369480
• Company Name: PASTURE PHARMA PTE LTD
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B624A520G0 [Unit of Use]
HIBCC	B624A520G200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083176

FDA Product Code

• NZJ: Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-01-03

Devices Manufactured by PASTURE PHARMA PTE LTD

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• B624A520G200 - Pasture A520G Respirator: 2020-05-06This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies.
• B624A520G200 - Pasture A520G Respirator: 2020-05-06 This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emer
• B624A520S200 - Pasture A520S Respirator: 2020-05-06 It is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personne
• B624E520CS200 - Pasture E520CS Respirator: 2020-05-06 It is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personne
• B624E520S200 - Pasture E520S Respirator: 2020-05-06 It is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personne
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• B624F550G200 - Pasture F550G Respirator: 2020-05-06 This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emer