Primary Device ID | 06945095511007 |
NIH Device Record Key | b09588ae-1566-4ae3-b774-908426e22ab9 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 06945095511007 [Primary] |
HLJ | Ophthalmoscope, Battery-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-09-27 |
Device Publish Date | 2018-08-27 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZUMAX 79131303 4486815 Live/Registered |
Zumax Medical Co., Ltd 2013-05-07 |
ZUMAX 76623638 3163227 Live/Registered |
TOPOWER CO., LTD. 2004-12-08 |