FDA UDI
In Commercial Distribution
🇺🇸 United States
ECO Series Diagnostic Ultrasound Systems
DI: 06945121407335
·
Model: ECO 3
·
CHISON Medical Technologies Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
9
Pkg Device Count
1
Basic Information
- Brand Name
- ECO Series Diagnostic Ultrasound Systems
- Primary DI
- 06945121407335
- Version / Model
- ECO 3
- Company Name
- CHISON Medical Technologies Co., Ltd.
- Labeler DUNS
- 544914187
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 73868da8-6895-40ac-82b6-97fa3b267f8a
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
- Yes
- 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 |
|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41917 | Foetal Doppler system probe | A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 06945121408073 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 06945121407335 | GS1 | ||||
| Package | 06945121408066 | GS1 | 1 | In Commercial Distribution | ||
| Package | 06945121408059 | GS1 | 1 | In Commercial Distribution | ||
| Package | 06945121408042 | GS1 | 1 | In Commercial Distribution | ||
| Package | 06945121408035 | GS1 | 1 | In Commercial Distribution | ||
| Package | 06945121408028 | GS1 | 1 | In Commercial Distribution | ||
| Package | 06945121408011 | GS1 | 1 | In Commercial Distribution | ||
| Package | 06945121408004 | GS1 | 1 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131305 | 000 |