FDA UDI
In Commercial Distribution
🇺🇸 United States
Airtraq
DI: 08436031035018
·
Model: A-501
·
PRODOL MEDITEC, SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Airtraq
- Primary DI
- 08436031035018
- Version / Model
- A-501
- Company Name
- PRODOL MEDITEC, SA
- Labeler DUNS
- 541001090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- New
- Public Device Record Key
- a7c0caa3-2c2e-4a22-b35b-0aaca0786c09
Device Description
Airtraq Avant Optics
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 Conditional
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 78436031035017 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 08436031035018 | GS1 |