EMAG® TIPS 1000µL

Basic Information

• Brand Name: EMAG® TIPS 1000µL
• Primary DI: 03573026615253
• Version / Model: EMAG® TIPS 1000µL
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2020-05-20
• Public Version: 3
• Public Version Date: 2022-09-26
• Public Version Status: Update
• Public Device Record Key: 61a96dfc-6e43-4eef-ae14-8b454a28d760

Device Description

Specific tips for eMAG system which is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use

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: Yes
• 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
JJH	CLINICAL SAMPLE CONCENTRATOR	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63337	Pipette tip IVD	A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette, or a dispenser, and where the required volume of liquid (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard automated liquid handling instruments or analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026489434	GS1		10	In Commercial Distribution
Primary	03573026615253	GS1
Unit of Use	03573026615246	GS1