zumax

GUDID 06945095516002

3.5V LED Coaxial Ophthalmoscope

Zumax Medical Co., LTD

Direct ophthalmoscope, battery-powered

• Primary Device ID: 06945095516002
• NIH Device Record Key: 61739ef8-3328-4adc-bd17-5292d5c7d95c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: zumax
• Version Model Number: DM6
• Company DUNS: 421348837
• Company Name: Zumax Medical Co., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	06945095516002 [Primary]

FDA Product Code

• HLJ: Ophthalmoscope, Battery-Powered

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: 2018-09-27
• Device Publish Date: 2018-08-27

On-Brand Devices [zumax]

• 06945095536000: 3.5V LED Streak Retinoscope，with Fixation Cards
• 06945095531999: Streak Retinoscope bulb,3.5V
• 06945095531982: Streak Retinoscope LED bulb,3.5V
• 06945095531302: Wall Mount streak retinoscope
• 06945095531203: Desk-top streak retinoscope
• 06945095531180: Rechargable streak retinoscope Set,with 489 handle，with DT801 charger，Zipper bag
• 06945095531005: 3.5V Streak Retinoscope，with Fixation Cards
• 06945095521990: Otoscope bulb,3.5V
• 06945095521983: Otoscope LED bulb,3.5V
• 06945095521006: 3.5V Otoscope
• 06945095520986: otoscope bulb 2.5V
• 06945095520955: 2.5V LED bulb
• 06945095520788: OT8C Otoscope head only
• 06945095520078: OT8C Otoscope, handle,Zipper Bag
• 06945095516002: 3.5V LED Coaxial Ophthalmoscope
• 06945095512004: 3.5V Pro Coaxial Ophthalmoscope
• 06945095511991: Ophthalmoscope Bulb,3.5V
• 06945095511984: Ophthalmoscope LED Bulb,3.5V
• 06945095511304: Wall Mount ophthalmoscope
• 06945095511205: Desk-top ophthalmoscope
• 06945095511182: Rechargable ophthalmoscope Set,with 489 handle，with DT801 charger，Zipper bag
• 06945095511007: 3.5V Coaxial Ophthalmoscope
• 06945095510888: DM6C ophthalmoscope,rechargable Lithium handle，charger,Zipper Bag
• 06945095510789: DM6C ophthalmoscope, handle，Zipper Bag
• 06945095510253: ophthalmocope bulb 2.5V
• 06945095510192: ophthalmoscope,B handle，Zipper Bag
• 06945095510000: DM6C Ophthalmoscope Head