FDA UDI
In Commercial Distribution
🇺🇸 United States
Insighter
DI: 06970831723338
·
Model: i6-M
·
Shenzhen Insighters Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Insighter
- Primary DI
- 06970831723338
- Version / Model
- i6-M
- Company Name
- Shenzhen Insighters Medical Technology Co., Ltd.
- Labeler DUNS
- 551096917
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-05
- Public Version
- 1
- Public Version Date
- 2023-01-13
- Public Version Status
- New
- Public Device Record Key
- fdf42eb5-209e-4262-ab41-80dbc4aaf631
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62760 | Video intubation laryngoscope blade | A rigid, blade-like component of a bladed video intubation laryngoscope intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has an electronic camera at its distal end to transmit anatomical images by a video system to a connected video intubation laryngoscope handle/monitor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970831723335 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 06970831723338 | GS1 | ||||
| Package | 26970831723332 | GS1 | 5 | In Commercial Distribution |