FDA UDI
In Commercial Distribution
🇺🇸 United States
Trachealator
DI: 06009698450009
·
Model: TRD1
·
DISA MEDINOTEC (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trachealator
- Primary DI
- 06009698450009
- Version / Model
- TRD1
- Company Name
- DISA MEDINOTEC (PTY) LTD
- Labeler DUNS
- 539157634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-02
- Public Version
- 1
- Public Version Date
- 2023-08-10
- Public Version Status
- New
- Public Device Record Key
- ac4a1c3f-d03c-4d30-bdf5-384da1c0b14e
Device Description
The Trachealator Non-occlusive Airway Dilation Balloon is comprised of a single lumen, over-the wire, catheter with a clustered balloon system near the distal tip. The balloon cluster, when inflated, features a inter balloon space to avoid airway occlusion during deployment. The inflated balloon cluster generates a strong outward force for dilation of airway strictures. A guidewire is provided to facilitate the advancement of the Trachealator Non-occlusive Airway Dilation Balloon to the desired location.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KTI | Bronchoscope Accessory | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17827 | Bronchial balloon catheter | A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06009698450009 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211894 | 000 |