Vacuette 454059P

GUDID 39120049204466

VACUETTE® TUBE 3,5 ml K2E K2EDTA Separator 13x75 lavender cap-yellow ring, non-ridged, USA

Greiner Bio-One GmbH

Evacuated blood collection tube IVD, K2EDTA/gel separator

• Primary Device ID: 39120049204466
• NIH Device Record Key: 86c92f20-9b6a-42c6-8396-3a081d89bb6b
• Commercial Distribution Discontinuation: 2017-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vacuette
• Version Model Number: 454059P
• Catalog Number: 454059P
• 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
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• 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	19120049204462 [Unit of Use]
GS1	29120049204469 [Primary]
GS1	39120049204466 [Package]; Contains: 29120049204469; Package: [24 Units]; Discontinued: 2017-10-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012043

FDA Product Code

• JKA: Tubes, vials, systems, serum separators, blood collection

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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• 39120049204558: VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 white cap-yellow ring, non-ridged, USA
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• 39120049204480: VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, non-ridged,
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