FDA UDI
In Commercial Distribution
🇺🇸 United States
Airtraq
DI: 00693602610717
·
Model: A-071
·
Prodol Meditec Limited
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
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Basic Information
- Brand Name
- Airtraq
- Primary DI
- 00693602610717
- Version / Model
- A-071
- Company Name
- Prodol Meditec Limited
- Labeler DUNS
- 421368931
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-16
- Public Version
- 2
- Public Version Date
- 2025-12-03
- Public Version Status
- Update
- Public Device Record Key
- 4d8372bd-5f84-45c5-afac-f4be38ec0a70
Device Description
Airtraq SP Video Laryngoscope Double Lumen Tubes
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
- 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 |
|---|---|---|---|---|
| 64798 | Video intubation laryngoscope imaging system | An assembly of video-imaging devices intended to be user-installed in a video intubation laryngoscope blade/handle shell (not included) to make functional a video intubation laryngoscope, enabling video imaging of the trachea during insertion of an endotracheal (ET) tube. It includes an electronic camera with integrated light, designed to be installed at the distal end of the blade, with dedicated software installed in a smartphone designed to be mounted on the handle; the smartphone provides power to, and receives image data from, the integrated camera. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40693602610715 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00693602610717 | GS1 | ||||
| Package | 10693602610714 | GS1 | 6 | In Commercial Distribution | ||
| Package | 30693602610718 | GS1 | 30 | In Commercial Distribution | ||
| Package | 80693602610713 | GS1 | USA | 30 | In Commercial Distribution |