FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00697077002572
·
Model: DS-KDM-CHFH-DAX
·
Amico Diagnostic Incorporated
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00697077002572
- Version / Model
- DS-KDM-CHFH-DAX
- Company Name
- Amico Diagnostic Incorporated
- Labeler DUNS
- 203163290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-17
- Public Version
- 2
- Public Version Date
- 2023-07-27
- Public Version Status
- Update
- Public Device Record Key
- eae415f0-a9e4-46e5-8858-9bb0845ba31b
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 |
| DXQ | Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16156 | Aneroid manual sphygmomanometer | A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope. | 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 | 00697077002572 | GS1 |