FDA UDI
In Commercial Distribution
🇺🇸 United States
TRACOE modular
DI: 04035324019151
·
Model: REF 650-TO-5
·
Tracoe medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- TRACOE modular
- Primary DI
- 04035324019151
- Version / Model
- REF 650-TO-5
- Catalog Number
- REF 650-TO-5
- Company Name
- Tracoe medical GmbH
- Labeler DUNS
- 319414785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2015-10-18
- Public Version
- 6
- Public Version Date
- 2024-11-29
- Public Version Status
- Update
- Public Device Record Key
- f4cb0f11-c1d4-4f3a-8537-8782b9120cd3
Device Description
TRACOE phon assist I with Oxygen Supply Port
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
- 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
- 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 |
|---|---|---|---|---|
| 36071 | Tracheostomy tube speech valve | A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035324019151 | GS1 | ||||
| Unit of Use | 05701780328418 | GS1 |
Customer Contacts
- Phone
- +49613691690
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043160 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Connector Compatibility Fits on 15 mm connector |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- 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.