NDDR (National Donor Deferral Registry)

GUDID 00812747010217

NDDR version 2.x.x

HAEMONETICS CORPORATION

Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software

• Primary Device ID: 00812747010217
• NIH Device Record Key: 39403e87-f8fb-432c-ba45-f83308dab5f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NDDR (National Donor Deferral Registry)
• Version Model Number: 2.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
• 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	00812747010217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK010012

FDA Product Code

• MMH: Blood Establishment Computer Software and Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-17
• Device Publish Date: 2020-08-07

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