iHealth

GUDID 10850044118257

IHEALTH LAB INC.

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent

• Primary Device ID: 10850044118257
• NIH Device Record Key: 8b1b46ee-9690-4f04-ac78-64be865962d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iHealth
• Version Model Number: EGS-2003
• Company DUNS: 054953337
• Company Name: IHEALTH LAB INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044118250 [Primary]
GS1	10850044118257 [Package]; Contains: 00850044118250; Package: [90 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170231

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-08-30

On-Brand Devices [iHealth]

• 00856362005258: TS28B
• 20856362005191: EGS-2003
• 10856362005019: ECG3
• 10855111003047: BP5
• 10856362005132: HS2S
• 10856362005040: PT3
• 00856362005609: PT2L
• 10856362005811: PT1
• 00850044118021: BP5S
• 10856362005996: PT5
• 10850044118004: KD-723
• 10856362005101: BP3L
• 10856362005095: BP3L
• 10856362005002: KN-550BT
• 10855111003955: BP3L
• 10850044118066: ICO-3000
• 10850044118059: ICO-3000
• 10850044118042: ICO-3000
• 10850044118035: HS2S Pro
• 10856362005057: BPM1
• 10855111003917: PO3M
• 10855111003276: PO3
• 00850044118083: PT3
• 10850044118202: EGS-2003
• 10850044118264: EGS-2003
• 10850044118257: EGS-2003
• 10850044118455: ICF-3000
• 10850044118431: ICF-3000
• 10850044118424: ICF-3000
• 10850044118240: BG5SKIT
• 10850044118233: BG5SKIT
• 10850044118783: F5043
• 10850044118868: ANC1