FDA UDI
In Commercial Distribution
🇺🇸 United States
Sensorendo
DI: 06974723790026
·
Model: S-VLB
·
Sensorendo Medical Technology (Zhuhai) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sensorendo
- Primary DI
- 06974723790026
- Version / Model
- S-VLB
- Company Name
- Sensorendo Medical Technology (Zhuhai) Co., Ltd.
- Labeler DUNS
- 722337994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-17
- Public Version
- 1
- Public Version Date
- 2023-01-25
- Public Version Status
- New
- Public Device Record Key
- 1cdae391-f4ae-4a34-abad-5fd7df565f1d
Device Description
S-VLB Laryngoscope blade
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
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 |
|---|---|---|---|---|---|---|
| Primary | 06974723790026 | GS1 | ||||
| Package | 16974723790092 | GS1 | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +8613602561980
- [email protected]