FDA UDI
In Commercial Distribution
🇺🇸 United States
Well Lead Tracheostomy Tube
DI: 06944932702851
·
Model: A02A046030
·
Well Lead Medical Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Well Lead Tracheostomy Tube
- Primary DI
- 06944932702851
- Version / Model
- A02A046030
- Company Name
- Well Lead Medical Co.,Ltd
- Labeler DUNS
- 544811862
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-21
- Public Version
- 1
- Public Version Date
- 2024-03-29
- Public Version Status
- New
- Public Device Record Key
- e702c220-9a04-45f8-a621-be94cdb2872c
Device Description
TRACHEOSTOMY TUBES (Uncuffed)I.D. 6.0
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
- No
- 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 |
|---|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35404 | Tracheostomy tube, non-reinforced, non-customized, single-use | A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16944932702858 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 06944932702851 | GS1 | ||||
| Package | 26944932702855 | GS1 | Carton | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042684 | 000 |