Vacuette SA1396

GUDID 39120049206866

VACUETTE® TUBE 5 ml Z No Additive 13x100 white cap-black ring

Greiner Bio-One GmbH

Evacuated blood collection tube IVD, no additive

• Primary Device ID: 39120049206866
• NIH Device Record Key: 1111aa87-1355-47e0-99eb-3d92230382b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vacuette
• Version Model Number: SA1396
• Catalog Number: SA1396
• 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	19120049206862 [Unit of Use]
GS1	29120049206869 [Primary]
GS1	39120049206866 [Package]; Contains: 29120049206869; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK040066

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: 2017-06-07

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• 39120049204565: VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 lavender cap-yellow ring, non-ridged, USA
• 39120049204558: VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 white cap-yellow ring, non-ridged, USA
• 39120049204541: VACUETTE® TUBE 9 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged,
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• 39120049204510: VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, non-ridged, USA
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• 39120049204497: VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-gold ring, black label,
• 39120049204480: VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, non-ridged,
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• 39120049201830: VACUETTE® TUBE 4 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, special label
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