FDA UDI
In Commercial Distribution
🇺🇸 United States
BIGTIDE
DI: 06970438060003
·
Model: HL5501S
·
Shenyang Torch-Bigtide Digital Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIGTIDE
- Primary DI
- 06970438060003
- Version / Model
- HL5501S
- Company Name
- Shenyang Torch-Bigtide Digital Technology Co., Ltd.
- Labeler DUNS
- 544970601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-05
- Public Version
- 4
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 126f87d5-efc0-4b8d-85b5-f32b845c58ae
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | Cardiovascular | 870.2450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36612 | Image display unit, colour | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970438060003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172969 | 000 |