FDA UDI
In Commercial Distribution
🇺🇸 United States
UESCOPE Disposable Laryngoscope Blade, Size 3
DI: 06970283481664
·
Model: UED-3
·
Zhejiang UE Medical Corp
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- UESCOPE Disposable Laryngoscope Blade, Size 3
- Primary DI
- 06970283481664
- Version / Model
- UED-3
- Company Name
- Zhejiang UE Medical Corp
- Labeler DUNS
- 542992969
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-09
- Public Version
- 1
- Public Version Date
- 2022-09-19
- Public Version Status
- New
- Public Device Record Key
- a9569f8b-1e85-47e3-9c94-7328bd012cd5
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
- 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 |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46828 | Laryngoscope blade, single-use | The segment of a laryngoscope (i.e., rigid intubation type) 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 is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970283481661 | GS1 | Carton | 50 | In Commercial Distribution | |
| Primary | 06970283481664 | GS1 | ||||
| Package | 26970283481668 | GS1 | Carton | 8 | In Commercial Distribution |