FDA UDI
In Commercial Distribution
🇺🇸 United States
CoPilot VL Disposable Bougie, Individual
DI: 00810049840198
·
Model: 1501
·
Dilon Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CoPilot VL Disposable Bougie, Individual
- Primary DI
- 00810049840198
- Version / Model
- 1501
- Catalog Number
- 1501
- Company Name
- Dilon Technologies, Inc.
- Labeler DUNS
- 061727272
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 07ffb97a-be4e-40bd-a692-2b909d243b14
Device Description
CoPilot VL Disposable Bougie, Individual
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
- No
- 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 | 00810049840198 | GS1 | ||||
| Package | 10810049840096 | GS1 | Box of 10 | 10 | In Commercial Distribution |