HAEMONETICS CELL SAVER ELITE SYSTEM

GUDID 30812747016562

WASTE BAG, 10L

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set

• Primary Device ID: 30812747016562
• NIH Device Record Key: b15db8c5-2231-4224-8cd5-68139b28bc71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS CELL SAVER ELITE SYSTEM
• Version Model Number: CSE-B-1000
• 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
• 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: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter
• Total Volume: 10 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747016568 [Primary]
GS1	20812747016565 [Package]; Contains: 10812747016568; Package: Dispenser [5 Units]; In Commercial Distribution
GS1	30812747016562 [Package]; Contains: 20812747016565; Package: Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101907

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: 2017-08-16

On-Brand Devices [HAEMONETICS CELL SAVER ELITE SYSTEM]

• 30812747016616: CELL SAVER ELITE
• 30812747016630: CS ELITE FASTPACK, 225ML, 20µ
• 30812747016586: CS ELITE FASTPACK,225ML,150µ
• 30812747016579: CS ELITE FASTPACK,125ML,150µ
• 30812747016562: WASTE BAG, 10L
• 30812747016555: SEQUESTRATION KIT
• 30812747016548: CS ELITE PROCESSING KIT (225ML)
• 30812747016531: CS ELITE PROCESSING KIT (125ML)
• 30812747016524: CS ELITE PROCESSING KIT (70ML)