m2000 04J71-60

GUDID 00884999006515

200 mL Reagent Vessels

ABBOTT MOLECULAR INC.

Assay container IVD, single-use

• Primary Device ID: 00884999006515
• NIH Device Record Key: 77093aaa-18d8-45f6-9f76-7b795e721d22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: m2000
• Version Model Number: 04J71-60
• Catalog Number: 04J71-60
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR INC.
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999006515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092705

FDA Product Code

• JJH: CLINICAL SAMPLE CONCENTRATOR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

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• 30884999046475: 5mL Reaction Vessels
• 30884999046451: 1000ul Pipette Tips
• 30884999046444: 200ul Pipette Tips
• 00884999043503: m2000rt SYSTEM SOFTWARE Release 8.0
• 00884999043497: m2000sp SYSTEM SOFTWARE, Release 8.0
• 00884999032064: Adhesive Cover Applicator
• 00884999032057: Splash Free Support Base
• 00884999031814: m2000rt Instrument System
• 00884999031753: m2000sp Instrument E-Series
• 00884999006911: STRIPRACK 16MM TUBES
• 00884999006898: STRIPRACK 13MM TUBES
• 00884999006577: Abbott m2000rt Optical Calibration Kit
• 00884999006539: Optical Adhesive Cover
• 00884999006522: 96-Well Optical Reaction Plate
• 00884999006515: 200 mL Reagent Vessels
• 00884999006492: Biohazard Bags
• 00884999006485: 96 Deep-Well Plates
• 00884999003668: Proteinase K, Recombinant, PCR Grade
• 00884999002883: Hood Assembly G-Series
• 00884999001381: m2000 System Pierceable Cap Sample Rack Set
• 00884999001350: m2000 System 16mm PoSt Set
• 00884999001343: m2000 System 13mm PoSt Set
• 00884999001336: m2000 System Pierceable Cap Sample Rack PoSt Set
• 00884999000414: Reagent Vessel Carrier Assembly
• 20884999046478: 5mL Reaction Vessels
• 20884999046454: 1000ul Pipette Tips
• 20884999046447: 200ul Pipette Tips
• 20884999046485: Master Mix Tubes