FDA UDI
In Commercial Distribution
🇺🇸 United States
TRACOE vario
DI: 04035324017003
·
Model: REF 450-07-P
·
Tracoe medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TRACOE vario
- Primary DI
- 04035324017003
- Version / Model
- REF 450-07-P
- Catalog Number
- REF 450-07-P
- Company Name
- Tracoe medical GmbH
- Labeler DUNS
- 319414785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-18
- Public Version
- 7
- Public Version Date
- 2024-11-29
- Public Version Status
- Update
- Public Device Record Key
- 05a3c5cb-378e-4ed1-9269-6b209a3bd84a
Device Description
TRACOE vario Tracheostomy Tube Spiral-Reinforced, with Adjustable Neck Flange and Low Pressure Cuff, with minimally traumatic insertion system
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47657 | Tracheostomy tube, reinforced, non-customized, single-use | An armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of 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 |
|---|---|---|---|---|---|---|
| Primary | 04035324017003 | GS1 |
Customer Contacts
- Phone
- +49613691690
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203362 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 7.0 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius