HAEMONETICS CELL SAVER 5/5+ SYSTEMS

GUDID 30812747016135

CELL SAVER 5/5+ BOWL KIT-225ML

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set

• Primary Device ID: 30812747016135
• NIH Device Record Key: 9b576dd7-da7f-4f2d-b752-ac74a9d04b1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS CELL SAVER 5/5+ SYSTEMS
• Version Model Number: 00263-00
• 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: true
• 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
• 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: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter
• Total Volume: 10 Liter
• Total Volume: 1000 Milliliter
• Total Volume: 225 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747016131 [Primary]
GS1	30812747016135 [Package]; Contains: 10812747016131; Package: Carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932890

FDA Product Code

• CAC: Apparatus, Autotransfusion

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: 2021-01-08
• Device Publish Date: 2015-09-24

On-Brand Devices [HAEMONETICS CELL SAVER 5/5+ SYSTEMS]

• 30812747016487: SEQUESTRATION SET
• 30812747016289: CELL SAVER 5/5+ BOWL KIT-70ML
• 30812747016142: CS5/5+ FASTPACK, 125ML, 150µ RES
• 30812747016135: CELL SAVER 5/5+ BOWL KIT-225ML
• 30812747016128: CELL SAVER 5/5+ BOWL KIT-125ML
• 30812747016111: CS5/5+ FASTPACK, 225ML 150U RES
• 30812747016104: 10 LITER WASTE BAG