MiniCollect

Basic Information

• Brand Name: MiniCollect
• Primary DI: 29120017578592
• Version / Model: 450477
• Catalog Number: 450477
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6de09850-a26d-4fba-8666-26a3b0baf6bf

Device Description

MiniCollect® TUBE 1 ml LH Lithium Heparin green cap, with cross cut, Spray-dried

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57902	Non-evacuated blood collection tube IVD, lithium heparin	A non-evacuated sterile glass or plastic tube, sealed with a stopper, containing the anticoagulant lithium heparin. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	39120017578599	GS1		10	In Commercial Distribution
Primary	29120017578592	GS1
Unit of Use	19120017578595	GS1

Premarket Submissions

Submission Number	Supplement Number
K991843	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius