MiniCollect 450476

GUDID 39120017578582

MiniCollect® TUBE 0.25 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried

Greiner Bio-One GmbH

Non-evacuated blood collection tube IVD, K3EDTA Non-evacuated blood collection tube IVD, K3EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA Capillary blood transfer tube IVD, EDTA

• Primary Device ID: 39120017578582
• NIH Device Record Key: de9f9a03-3326-4654-bcbf-6dc9713feb2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniCollect
• Version Model Number: 450476
• Catalog Number: 450476
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	19120017578588 [Unit of Use]
GS1	29120017578585 [Primary]
GS1	39120017578582 [Package]; Contains: 29120017578585; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982999

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]

• 49120049206030: MiniCollect® Complete 0.25 / 0.5 ml K2E K2EDTA lavender cap, pre-assembled with Carrier Tube 13
• 39120049203568: MiniCollect® TUBE 0.25 / 0.5 ml K2E K2EDTA lavender cap
• 39120017578629: MiniCollect® TUBE 0.8 ml LH Lithium Heparin Separator light-green cap, with cross cut, Spray-dr
• 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