Atom Phototherapy Analyzer Ⅱ

Basic Information

• Brand Name: Atom Phototherapy Analyzer Ⅱ
• Primary DI: 04942962684484
• Version / Model: 68448
• Catalog Number: 68448
• Company Name: ATOM MEDICAL CORPORATION
• Labeler DUNS: 690632047
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2019-01-29
• Public Version Status: Update
• Public Device Record Key: f1902d15-4d1b-4725-b62c-9cfdad1a5e6c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	862.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35827	Photometer, reflectance	An instrument that measures the amount of light emitted by a light source, e.g., a light-emitting diode, as reflected from a sample in order to determine the concentration of an element. The device usually contains a photodiode for light detection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04942962684484	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]