FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00697077002299
·
Model: DS-UR1-CLFL-DXO
·
Amico Diagnostic Incorporated
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00697077002299
- Version / Model
- DS-UR1-CLFL-DXO
- Company Name
- Amico Diagnostic Incorporated
- Labeler DUNS
- 203163290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-05
- Public Version
- 3
- Public Version Date
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- 487bfdf6-1757-4d61-af49-bbde51fffb19
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | 886.1570 | 2 |
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14035 | Intermittent electronic patient thermometer | A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device. | No | Active |
| 46786 | Direct ophthalmoscope | An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00697077002299 | GS1 |