iHealth

Basic Information

• Brand Name: iHealth
• Primary DI: 00850044118205
• Version / Model: EGS-2003
• Company Name: IHEALTH LAB INC.
• Labeler DUNS: 054953337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-24
• Public Version: 2
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 6103acf1-83e0-4deb-b5e7-89af4e7368b9

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55937	Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850044118202	GS1		50	In Commercial Distribution
Primary	00850044118205	GS1
Package	20850044118209	GS1		100	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K170231	000