MCS+ (LN8150) RBC APHERESIS

GUDID 30812747013516

2 UNIT RED CELL SET W/RC2H FIL

HAEMONETICS CORPORATION

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• Primary Device ID: 30812747013516
• NIH Device Record Key: 0c169ca2-23d8-4720-8bc0-fa7ff26cd9e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MCS+ (LN8150) RBC APHERESIS
• Version Model Number: 0832F-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: 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

Device Dimensions

• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 600 Milliliter
• Total Volume: 1000 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747013512 [Primary]
GS1	30812747013516 [Package]; Contains: 10812747013512; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK040041

FDA Product Code

• GKT: Separator, automated, blood cell, diagnostic

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: 2017-02-08

Devices Manufactured by HAEMONETICS CORPORATION

• 20812747018538 - Global Hemostasis - HN: 2024-04-18 CITRATED: K, KH, RTH, FFH
• 30812747013516 - MCS+ (LN8150) RBC APHERESIS: 2023-10-192 UNIT RED CELL SET W/RC2H FIL
• 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