GUDID 20650862124501

BLOOD BAG, ATS SELF-FILLING

ATRIUM MEDICAL CORPORATION

Blood-processing autotransfusion system

• Primary Device ID: 20650862124501
• NIH Device Record Key: aa1ba260-ff3d-48b4-96e9-bcc65979263e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2450
• Company DUNS: 051798999
• Company Name: ATRIUM MEDICAL 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650862124507 [Primary]
GS1	20650862124501 [Package]; Contains: 00650862124507; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883663

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

Devices Manufactured by ATRIUM MEDICAL CORPORATION

• 00650862122916 - iCast covered stent system, 12mm x 29mm x 80cm: 2026-02-26 iCast covered stent system, 12mm x 29mm x 80cm
• 00650862122923 - iCast covered stent system, 12mm x 29mm x 120cm: 2026-02-26 iCast covered stent system, 12mm x 29mm x 120cm
• 00650862124118 - iCast covered stent system, 12mm x 41mm x 80cm: 2026-02-26 iCast covered stent system, 12mm x 41mm x 80cm
• 00650862124125 - iCast covered stent system, 12mm x 41mm x 120cm: 2026-02-26 iCast covered stent system, 12mm x 41mm x 120cm
• 00650862126112 - iCast covered stent system, 12mm x 61mm x 80cm: 2026-02-26 iCast covered stent system, 12mm x 61mm x 80cm
• 00650862126129 - iCast covered stent system, 12mm x 61mm x 120cm: 2026-02-26 iCast covered stent system, 12mm x 61mm x 120cm
• 00650862425321 - iCast covered stent system, 5mm x 32mm x 120cm: 2026-02-26 iCast covered stent system, 5mm x 32mm x 120cm
• 00650862426328 - iCast covered stent system, 6mm x 32mm x 120cm: 2026-02-26 iCast covered stent system, 6mm x 32mm x 120cm