FDA UDI
In Commercial Distribution
🇺🇸 United States
TRACOE® care
DI: 04035324012268
·
Model: REF 941
·
Tracoe medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRACOE® care
- Primary DI
- 04035324012268
- Version / Model
- REF 941
- Company Name
- Tracoe medical GmbH
- Labeler DUNS
- 319414785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-03-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 060e5b97-77dc-4eed-8705-3a7a88d6911b
Device Description
TRACOE cleaning brushes for flexible tracheostomy tubes set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EPE | BRUSH, CLEANING, TRACHEAL TUBE | Anesthesiology | 868.5795 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34883 | Airway device cleaning utensil, noninvasive, reusable | A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035324012268 | GS1 |
Customer Contacts
- Phone
- +49613691690
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | mix of different sizes |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- no special storage conditions