HAEMONETICS R.I.S. SYSTEM

GUDID 20812747016220

EXTENSION LINES

HAEMONETICS CORPORATION

Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set Conduction blood/fluid warmer set

• Primary Device ID: 20812747016220
• NIH Device Record Key: 604600e2-d04c-4bf1-b9aa-038b245dbb01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS R.I.S. SYSTEM
• Version Model Number: 00401-00
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• Device Count: 2
• 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
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• 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	00812747016226 [Unit of Use]
GS1	20812747016220 [Primary]
GS1	30812747016227 [Package]; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852645

FDA Product Code

• FRN: Pump, Infusion

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: 2015-09-24

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