Vacuette 454323

GUDID 39120017574492

VACUETTE® TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged, High Altitude

Greiner Bio-One GmbH

Evacuated blood collection tube IVD, sodium citrate

• Primary Device ID: 39120017574492
• NIH Device Record Key: 08c19b04-40d4-4466-b4db-401076f0640f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vacuette
• Version Model Number: 454323
• Catalog Number: 454323
• Company DUNS: 303639066
• Company Name: Greiner Bio-One GmbH
• Device Count: 50
• 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

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	19120017574498 [Unit of Use]
GS1	29120017574495 [Primary]
GS1	39120017574492 [Package]; Contains: 29120017574495; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971221

FDA Product Code

• GIM: Tubes, vacuum sample, with anticoagulant

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: 2016-09-23

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