Thermo Scientific Nerl®

Basic Information

• Brand Name: Thermo Scientific Nerl®
• Primary DI: 00845275004717
• Version / Model: JDIL5522
• Company Name: Fisher Diagnostics
• Labeler DUNS: 183998769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-13
• Public Version: 2
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 40e1d147-18a9-4605-ba33-ebf8da83a4db

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GIF	Diluent, Blood Cell	Hematology	864.8200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845275004717	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius