HAEMONETICS PCS 300 PLASMA COLLECTION SYSTEM

GUDID 30812747011659

PCS 300, US

HAEMONETICS CORPORATION

Blood-processing autotransfusion system set Blood-processing autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Red blood cell-recovery autotransfusion system set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing set Autotransfusion system blood component processing 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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• 30812747015008 - HAEMONETICS ACP 215 SYSTEM: 2023-10-19 RBC GLYCEROLIZATION SET
• 30812747015015 - HAEMONETICS ACP 215 SYSTEM: 2023-10-19 RBC DE-GLYCEROL./CELL WASH SET
• 30812747015022 - HAEMONETICS ACP 215 SYSTEM: 2023-10-19 RBC DE-GLYCEROL. SET 325ML BMB
• 10812747018043 - TEG HEMOSTASIS SYSTEM: 2023-10-10 CALCIUM CHLORIDE, 0.2M, 5 ML
• 30812747019334 - Haemonetics® NexSys PCS® System: 2023-07-07 0625Q-00 Plasma Bowl
• 30812747012861 - MCS 9000: 2023-02-15