HAEMONETICS PCS2 APHERESIS SYSTEMS

GUDID 30812747011529

PLASMA POOLING BOTTLE

HAEMONETICS CORPORATION

Apheresis system tubing set Apheresis system tubing set

• Primary Device ID: 30812747011529
• NIH Device Record Key: 454dac85-e1b6-4579-9d06-d73ee558d6d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS PCS2 APHERESIS SYSTEMS
• Version Model Number: 00694-00
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	30812747011529 [Primary]
GS1	30812747011772 [Package]; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK020001

FDA Product Code

• KSR: CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-17
• Device Publish Date: 2017-03-20

Devices Manufactured by HAEMONETICS CORPORATION

• 20812747018538 - Global Hemostasis - HN: 2024-04-18 CITRATED: K, KH, RTH, FFH
• 30812747013516 - MCS+ (LN8150) RBC APHERESIS: 2023-10-19 2 UNIT RED CELL SET W/RC2H FIL
• 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