Haemonetics® PCS®2 & NexSys PCS™ Systems

GUDID 30812747011673

Plasma Bottles with Saline Adapter

HAEMONETICS CORPORATION

Apheresis system tubing set

• Primary Device ID: 30812747011673
• NIH Device Record Key: d0a04248-e15b-4663-97dd-ce12920c6171
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Haemonetics® PCS®2 & NexSys PCS™ Systems
• Version Model Number: 0694S-00
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• Device Count: 15
• 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	00812747011672 [Unit of Use]
GS1	30812747011673 [Primary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-16

Devices Manufactured by HAEMONETICS CORPORATION

• 00812747019807 - Haemonetics® NexSys PCS® System: 2024-10-18 Persona™ Plasma Pooling Bottles
• 30812747019273 - Haemonetics® PCS®2 & NexSys PCS® Systems: 2024-07-29 PLS HARNESS SET
• 30812747019341 - Haemonetics® PCS®2 & NexSys PCS® Systems: 2024-07-29 PLS HARNESS SET
• 30812747019730 - Haemonetics® NexSys PCS® System: 2024-07-25 0625Q-00 Plasma Bowl
• 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