PAXgene® Blood DNA Tube 761165

GUDID 04053727611659

PAX DNA IVD BLOOD COLLECTION TUBE

PreAnalytiX GmbH

Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer

• Primary Device ID: 04053727611659
• NIH Device Record Key: dfdc9d7c-12c5-4ac7-b3ce-0a2e8bceb0cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAXgene® Blood DNA Tube
• Version Model Number: 761165
• Catalog Number: 761165
• Company DUNS: 480915029
• Company Name: PreAnalytiX GmbH
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053727611659 [Primary]
GS1	34053727611650 [Package]; Package: Shelfpack [100 Units]; In Commercial Distribution
GS1	54053727611654 [Package]; Package: Case [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231469

FDA Product Code

• PJE: Blood/plasma collection device for DNA testing

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: 2023-11-09
• Device Publish Date: 2016-07-28

On-Brand Devices [PAXgene® Blood DNA Tube]

• 54053727611654: PAXgene® Blood DNA Tube
• 04053727611659: PAX DNA IVD BLOOD COLLECTION TUBE