FDA UDI
In Commercial Distribution
🇺🇸 United States
BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for
DI: 05055788773559
·
Model: 041-814U
·
FLEXICARE MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for
- Primary DI
- 05055788773559
- Version / Model
- 041-814U
- Company Name
- FLEXICARE MEDICAL LIMITED
- Labeler DUNS
- 504406273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-24
- Public Version
- 1
- Public Version Date
- 2020-02-03
- Public Version Status
- New
- Public Device Record Key
- 3c01dc9a-0e9a-444e-8a4a-c02e953bb1b5
Device Description
BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for Mini/Penlight Handle
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 60381 | Laryngoscope light-emitting cell | A non-sterile, portable, battery-powered device intended to provide the light source for a laryngoscope (i.e., rigid intubation type) when fitted into the laryngoscope handle. It typically consists of a removable cylindrical cell that produces light which is emitted from the laryngoscope handle via a fibreoptic laryngoscope blade for airway illumination. The device may be kinetically or electrically recharged. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055788773559 | GS1 |