Profiler Paper

Basic Information

• Brand Name: Profiler Paper
• Primary DI: G0561013751
• Version / Model: 101375
• Catalog Number: 101375
• Company Name: Bio/Data Corporation
• Labeler DUNS: 051392959
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-30
• Public Version: 1
• Public Version Date: 2023-09-07
• Public Version Status: New
• Public Device Record Key: af300c5d-90d4-4af9-a593-aa526108ab1b

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
DSF	Recorder, Paper Chart	Cardiovascular	870.2810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65796	Medical printer paper IVD	A thin sheet of fibrous material intended to be used to produce a hard copy of printed data/images generated by an in vitro diagnostic device (e.g., laboratory instrument/analyser). It is typically available as a continuous length of paper (e.g., roll or accordion) or as individual sheets of paper; some types are pre-treated with thermochromic ink for use with thermal printers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G0561013751	HIBCC