HAEMONETICS ORTHOPAT & CARDIOPAT SYSTEMS

GUDID 30812747017026

400 ML RBC BAG

HAEMONETICS CORPORATION

Red blood cell-recovery autotransfusion system set

• Primary Device ID: 30812747017026
• NIH Device Record Key: ab426d7e-0305-402e-a62f-ca76ff094768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HAEMONETICS ORTHOPAT & CARDIOPAT SYSTEMS
• Version Model Number: 01200-00
• 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
• 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: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter
• Total Volume: 400 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747017022 [Primary]
GS1	30812747017026 [Package]; Contains: 10812747017022; Package: Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962475

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 ORTHOPAT & CARDIOPAT SYSTEMS]

• 30812747017200: ASPIRATION & ANTICOAG LINE
• 30812747017033: 3 LITER WASTE BAG
• 30812747017026: 400 ML RBC BAG