FDA UDI
In Commercial Distribution
🇺🇸 United States
Smart VIdeo-Stylet Monitor
DI: B881SSCNDK0
·
Model: S-SC-NDK
·
SMART VIDEO-STYLET, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Smart VIdeo-Stylet Monitor
- Primary DI
- B881SSCNDK0
- Version / Model
- S-SC-NDK
- Catalog Number
- S-SC-NDK
- Company Name
- SMART VIDEO-STYLET, LLC
- Labeler DUNS
- 113503058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-29
- Public Version
- 1
- Public Version Date
- 2020-12-07
- Public Version Status
- New
- Public Device Record Key
- f089b93b-3eda-4f7e-a882-7ca17d7340b1
- Distribution End Date
- 2120-11-28
Device Description
Monitor with connecting and re-charging cables, to be used with video-stylet (comes with IV pole mount)
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62762 | Rigid non-bladed video intubation laryngoscope | A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It consists of a thin tubular portion inserted into the ET tube prior to intubation, with an electronic camera at its distal end to transmit anatomical images by a video system to a handle/monitor. It is typically made of memory-alloy material to allow moulding into a shape to facilitate intubation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B881SSCNDK0 | HIBCC |