StatFax

Basic Information

• Brand Name: StatFax
• Primary DI: 00850229007089
• Version / Model: 2200
• Company Name: AWARENESS TECHNOLOGY, INCORPORATED
• Labeler DUNS: 071065130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-05
• Public Version: 1
• Public Version Date: 2023-06-13
• Public Version Status: New
• Public Device Record Key: 2701b4d5-447b-409a-904d-56490c5f1680

Device Description

Digital Dry Bath

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: Yes
• 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
JTQ	Bath, Incubators/Water, All	Microbiology	866.2540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15178	Laboratory shaker	An electromechanical device, typically used in the laboratory or a blood bank, designed to shake/stir samples or mixtures with a rapid and forceful movement. It is used to provide a rapid mixing or to prevent substances comprised of different components from separation or sedimentation because of their different densities. It may be designed to secure single and/or multiple specimen containers (e.g., test tube, microplate) or specimen container holders during the shaking cycle; some types may have selectable agitation frequencies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850229007089	GS1