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

• 00650862420388 - iCast Covered Stent System, 10mmX38mmX120cm: 2023-06-19 iCast Covered Stent System, 10mmX38mmX120cm
• 00650862425161 - iCast Covered Stent System, 5mmX16mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX16mmX120cm
• 00650862425222 - iCast Covered Stent System, 5mmX22mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX22mmX120cm
• 00650862425383 - iCast Covered Stent System, 5mmX38mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX38mmX120cm
• 00650862425598 - iCast Covered Stent System, 5mmX59mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX59mmX120cm
• 00650862426168 - iCast Covered Stent System, 6mmX16mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX16mmX120cm
• 00650862426229 - iCast Covered Stent System, 6mmX22mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX22mmX120cm
• 00650862426380 - iCast Covered Stent System, 6mmX38mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX38mmX120cm