Welch Allyn, Inc.
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including mounting bracket for Connex Spot Monitor Device (order CSM device separately), Coaxial Ophthalmoscope (#11720),…
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including mounting bracket for Connex Spot Monitor Device (order CSM device separately), Coaxial Ophthalmoscope (#11720), MacroView Otoscope (# 23810), KleenSpec Disposable Specula Dispenser, Vital Signs Accessory Basket, Vital Signs Monitor Power Supply (7000-PS) Wall-Mount Panel, (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (1), Shaanxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | HMF |
| Device type | Stand, Instrument, Ac-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1860 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2021-07-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2019-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901027 | In distribution | |
| 901091 | In distribution | |
| 901027 | In distribution | |
| 901093 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn | |
| 901027 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reliance | Haag-Streit USA, Inc. | 19 |
| AtriCure System Cart | Atricure, Inc. | 19 |
| Refraction Unit | MDT SP. Z O.O. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 10 |
| Marco | Takagi Seiko Co., Ltd. | 7 |
| Mckesson | Mckesson Medical-Surgical Inc. | 6 |
| IS-5500 | Topcon Corp. | 5 |
| IS-5000 | Topcon Corp. | 2 |
| KXL System | Avedro, Inc. | 2 |
| IS-6500 | Topcon Corp. | 2 |
| Legion | Alcon Laboratories, Inc. | 1 |
| i.Terminal 2 Station | Carl Zeiss Vision Gmbh | 1 |
Showing 12 of 19. All products under Stand, Instrument, Ac-Powered, Ophthalmic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.