HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM

GUDID 30812747012816

MCS+ ,110V ENGL, LN 09000-110-E

HAEMONETICS CORPORATION

Apheresis system Apheresis system

• Primary Device ID: 30812747012816
• NIH Device Record Key: 1a53de9c-0104-46b4-8066-b46ebea097ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM
• Version Model Number: 09000-110-E
• 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: false
• Serial Number: true
• 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	30812747012816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK050047

FDA Product Code

• GKT: Separator, automated, blood cell, diagnostic

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: 2017-02-06

On-Brand Devices [HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM]

• 30812747012878: MCS+, 220V, LN09000-220-EW-RU
• 30812747012854: MCS+, 220V ENGL, LN 09000-220-E
• 30812747012816: MCS+ ,110V ENGL, LN 09000-110-E