HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM

GUDID 30812747011659

PCS 300, US

HAEMONETICS CORPORATION

Blood-processing autotransfusion system set

• Primary Device ID: 30812747011659
• NIH Device Record Key: 44a7f835-5828-4a6c-a367-fa9f57ad0771
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM
• Version Model Number: PCS-300-US
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com
• Phone: +1(800)-537-2802
• Email: ProductSupport@haemonetics.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	30812747011659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK170045

FDA Product Code

• GKT: Separator, automated, blood cell, diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-01

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