FDA UDI
In Commercial Distribution
🇺🇸 United States
TRACOE® modular
DI: 04035324057016
·
Model: REF 621
·
Tracoe medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRACOE® modular
- Primary DI
- 04035324057016
- Version / Model
- REF 621
- Company Name
- Tracoe medical GmbH
- Labeler DUNS
- 319414785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-17
- Public Version
- 1
- Public Version Date
- 2023-06-26
- Public Version Status
- New
- Public Device Record Key
- 98461997-3387-4aaf-bf9e-41261050112e
Device Description
modular Stopper for temporary closure of the 22 mm housing, 5 units
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
- 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 |
|---|---|---|---|---|
| 47119 | Tracheostomy tube decannulation cap | A device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy identification, that is placed on the proximal end of a fenestrated or uncuffed tracheostomy tube to close the tracheostomy termination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035324057016 | GS1 |
Customer Contacts
- Phone
- +49613691690
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961449 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Fits on 22 mm connector |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- no Special Storage Conditions