Acrodose PLus System

GUDID 30887691308193

Pool and Store Set for Leukocyte-Reduced Platelets

HAEMONETICS CORPORATION

Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container

• Primary Device ID: 30887691308193
• NIH Device Record Key: e9bcc42c-311b-42b9-87cb-ca3273809357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acrodose PLus System
• Version Model Number: 732-86
• 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: 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	10887691308199 [Primary]
GS1	30887691308193 [Package]; Contains: 10887691308199; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK060045

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: 2016-12-15

On-Brand Devices [Acrodose PLus System]

• 30887691310691: Platelet Pool and Store Set with In-line Leukocyte Redcution Filter
• 30887691310684: Platelet Pool and Store Set with In-Line Leukocyte Reduction Filter and eBDS
• 30887691308193: Pool and Store Set for Leukocyte-Reduced Platelets