FDA UDI
In Commercial Distribution
🇺🇸 United States
Airtraq
DI: 00693602616146
·
Model: A6M1
·
Prodol Meditec Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Airtraq
- Primary DI
- 00693602616146
- Version / Model
- A6M1
- Company Name
- Prodol Meditec Limited
- Labeler DUNS
- 421368931
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-19
- Public Version
- 1
- Public Version Date
- 2025-03-27
- Public Version Status
- New
- Public Device Record Key
- 6ee7a057-29a8-4d22-8cc0-bccdcc03d7eb
Device Description
Airtraq Plus Video Laryngoscope Mac Blade Size 1
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 64797 | Video intubation laryngoscope blade/handle shell | A non-electronic, hand-held component of a video intubation laryngoscope intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube. It is designed as a user-assembled casing intended to accept a digital camera with light source (not included) at the distal blade end, and a smartphone (not included) within the handle, to provide video imaging. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00693602616146 | GS1 | ||||
| Package | 60693602616148 | GS1 | 10 | In Commercial Distribution | ||
| Package | 50693602616141 | GS1 | 50 | In Commercial Distribution |