NEGA Open Heart *RFID PB

GUDID 00817395023824

NEGA Open Heart *RFID PB

PACKROOM LLC

Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use Cardiothoracic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00817395023824
• NIH Device Record Key: dee8483c-3aba-49d2-8f33-cf49c9bd4329
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEGA Open Heart *RFID PB
• Version Model Number: CDS840132RFPBO
• Company DUNS: 015179820
• Company Name: PACKROOM LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817395023824 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-27
• Device Publish Date: 2024-03-19

Devices Manufactured by PACKROOM LLC

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• 00817395023824 - NEGA Open Heart *RFID PB: 2024-03-27 NEGA Open Heart *RFID PB
• 00817395023824 - NEGA Open Heart *RFID PB: 2024-03-27 NEGA Open Heart *RFID PB
• 00817395023831 - Lithotomy Pack *RFID PB: 2024-03-27 Lithotomy Pack *RFID PB
• 00817395023596 - Barrow Podiatry *RFID PB: 2024-03-26 Barrow Podiatry *RFID PB
• 00817395023602 - NEGA Arthroscopy *RFID PB: 2024-03-26 NEGA Arthroscopy *RFID PB
• 00817395023619 - NEGA Thoracic CVOR *RFID PB: 2024-03-26 NEGA Thoracic CVOR *RFID PB
• 00817395023626 - NEGA C-Section *RFID PB: 2024-03-26 NEGA C-Section *RFID PB Huntsville Vag Perineal
• 00817395023633 - NEGA Cysto *RFID PB: 2024-03-26 NEGA Cysto *RFID PB