NextGen

GUDID 00812747010057

NextGen version 4.x.x

HAEMONETICS CORPORATION

Blood bank information system application software

• Primary Device ID: 00812747010057
• NIH Device Record Key: 62799c7d-31f6-4293-accd-afaf30f9d6db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextGen
• Version Model Number: 4.x.x
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00812747010057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150330

FDA Product Code

• MMH: SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS

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: 2016-11-18

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