FDA UDI
In Commercial Distribution
🇺🇸 United States
Flexicare
DI: 05055788787129
·
Model: 040-12-2135U
·
FLEXICARE MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Flexicare
- Primary DI
- 05055788787129
- Version / Model
- 040-12-2135U
- Company Name
- FLEXICARE MEDICAL LIMITED
- Labeler DUNS
- 504406273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-31
- Public Version
- 1
- Public Version Date
- 2026-04-08
- Public Version Status
- New
- Public Device Record Key
- 8422fe8a-023a-427e-9e63-536a365e494d
Device Description
ProVu Lite Video Laryngoscope Hyperangulated 3.5 Handle and Blade
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 |
|---|---|---|---|---|
| 62763 | Video intubation laryngoscope kit | A collection of video laryngoscopic devices intended to be used for various procedures on the airway and respiratory tract including intubation, lung dual-chamber positioning, suction, biopsy, drug administration and oxygen giving. It typically consists of a set of video intubation laryngoscope blades, a video intubation laryngoscope handle/monitor, a rigid non-bladed video intubation laryngoscope and a flexible video intubation laryngoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055788787129 | GS1 |