HAEMONETICS ACP 215 SYSTEM

GUDID 30812747015008

RBC GLYCEROLIZATION SET

HAEMONETICS CORPORATION

Blood cell freeze/thaw system set

• Primary Device ID: 30812747015008
• NIH Device Record Key: dc8e48a2-b2b0-4021-aef6-0b8129a84f75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS ACP 215 SYSTEM
• Version Model Number: 00225-00
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747015004 [Primary]
GS1	30812747015008 [Package]; Contains: 10812747015004; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK040077

FDA Product Code

• KSW: SYSTEM, PROCESSING FOR FROZEN BLOOD

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: 2023-10-19
• Device Publish Date: 2017-02-07

On-Brand Devices [HAEMONETICS ACP 215 SYSTEM]

• 30812747015022: RBC DE-GLYCEROL. SET 325ML BMB
• 30812747015015: RBC DE-GLYCEROL./CELL WASH SET
• 30812747015008: RBC GLYCEROLIZATION SET