HAEMONETICS CELL SAVER SYSTEMS

GUDID 30812747016098

RBC BAG W/TWIST LOCK, 1000ML

HAEMONETICS CORPORATION

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• Primary Device ID: 30812747016098
• NIH Device Record Key: 8942c0be-58ad-4266-b22d-8fdf2e9b62d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS CELL SAVER SYSTEMS
• Version Model Number: 00245-00
• 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: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: 800-537-2802
• Email: pirdesk@Haemonetics.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747016094 [Primary]
GS1	20812747016091 [Package]; Contains: 10812747016094; Package: Dispenser [10 Units]; In Commercial Distribution
GS1	30812747016098 [Package]; Contains: 20812747016091; Package: Carton [4 Units]

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: 2017-06-27

On-Brand Devices [HAEMONETICS CELL SAVER SYSTEMS]

• 30812747016098: RBC BAG W/TWIST LOCK, 1000ML
• 30812747016012: WASTE BAG, 5L
• 30812747016005: RBC BAG WITH LUER LOCK, 600ML