FDA UDI
In Commercial Distribution
🇺🇸 United States
Insighters
DI: 06970831726186
·
Model: Power Adapter
·
Shenzhen Insighters Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Insighters
- Primary DI
- 06970831726186
- Version / Model
- Power Adapter
- Catalog Number
- 868.554
- 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
- 2023-04-08
- Public Version
- 1
- Public Version Date
- 2023-04-17
- Public Version Status
- New
- Public Device Record Key
- 8005be71-98b1-4277-88ea-47416a9b8263
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62761 | Video intubation laryngoscope handle/monitor | A non-sterile component of a bladed video intubation laryngoscope intended to enable the positioning of the blade 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 a monitor for the user to view anatomical images of the larynx/trachea transmitted by a video system from an electronic camera at the distal end of the blade. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970831726186 | GS1 |