MiniCollect 450480

GUDID 39120017570425

MiniCollect® TUBE 0.5 ml K2E K2EDTA lavender cap, with cross cut, Spray-dried

Greiner Bio-One GmbH

Non-evacuated blood collection tube IVD, K2EDTA

• Primary Device ID: 39120017570425
• NIH Device Record Key: 21ec53de-35ed-4e7d-8b6a-f571b6dd2079
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniCollect
• Version Model Number: 450480
• Catalog Number: 450480
• Company DUNS: 303639066
• Company Name: Greiner Bio-One GmbH
• Device Count: 100
• 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
• 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
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	19120017570421 [Unit of Use]
GS1	29120017570428 [Primary]
GS1	39120017570425 [Package]; Contains: 29120017570428; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063357

FDA Product Code

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

Sterilization

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

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

On-Brand Devices [MiniCollect]

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• 39120049203568: MiniCollect® TUBE 0.25 / 0.5 ml K2E K2EDTA lavender cap
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• 39120017578612: MiniCollect® TUBE 0.5 ml LH Lithium Heparin green cap, with cross cut, Spray-dried
• 39120017578599: MiniCollect® TUBE 1 ml LH Lithium Heparin green cap, with cross cut, Spray-dried
• 39120017578582: MiniCollect® TUBE 0.25 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried
• 39120017578551: MiniCollect® TUBE 1 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried
• 39120017578537: MiniCollect® TUBE 0.5 ml Z Serum red cap, with cross cut, Spray-dried
• 39120017578513: MiniCollect® TUBE 1 ml Z Serum red cap, with cross cut, Spray-dried
• 39120017578506: MiniCollect® TUBE 0.5 ml 9NC Coagulation sodium citrate 3.2% blue cap, with cross cut
• 39120017578445: MiniCollect® TUBE 1 ml 9NC Coagulation sodium citrate 3.2% blue cap, with cross cut
• 39120017578421: MiniCollect® TUBE 1 ml 9NC Coagulation sodium citrate 3.8% blue cap, with cross cut
• 39120017577424: MiniCollect® TUBE 0.5 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried
• 39120017570883: MiniCollect® TUBE 0.5 ml Z Serum Separator gold cap, with cross cut, Spray-dried
• 39120017570760: MiniCollect® TUBE 0.8 ml Z Serum Separator gold cap, with cross cut, Spray-dried
• 39120017570425: MiniCollect® TUBE 0.5 ml K2E K2EDTA lavender cap, with cross cut, Spray-dried
• 39120017578476: MiniCollect® Carrier Tube clear, 13x75
• 39120017578469: MiniCollect® Carrier Tube amber, for bilirubin, 13x75
• 49120017578718: MiniCollect® Capillary for Heparin, 80 µL
• 49120017578695: MiniCollect® Capillary for EDTA, 250 µL
• 49120017571009: MiniCollect® Capillary for EDTA, 80 µL
• 49120017570996: MiniCollect® Capillary for Serum, 80 µL
• 39120017570937: MiniCollect® Funnel
• 39120017570043: MiniCollect® Safety Lancet penetration depth 2.00 mm blue, for capillary blood collection, ster
• 39120049202240: MiniCollect® Lancelino Safety Lancet penetration depth 2.00 mm yellow, sterile, for capillary b
• 39120049202233: MiniCollect® Lancelino Safety Lancet 21G penetration depth 2.40 mm green, sterile, for capillar
• 39120049202226: MiniCollect® Lancelino Safety Lancet 21G penetration depth 1.80 mm blue, sterile, for capillary
• 39120049202219: MiniCollect® Lancelino Safety Lancet 25G penetration depth 1,50 mm lavender, sterile, for capil
• 39120049202202: MiniCollect® Lancelino Safety Lancet 30G penetration depth 1.20 mm light-green, sterile, for ca
• 39120017578902: MiniCollect® Safety Lancet 28G, penetration depth 1.25 mm lavender, for capillary blood collect