FDA UDI
In Commercial Distribution
🇺🇸 United States
TRACOE care
DI: 04035324064014
·
Model: REF 903-F
·
Tracoe medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TRACOE care
- Primary DI
- 04035324064014
- Version / Model
- REF 903-F
- Catalog Number
- REF 903-F
- Company Name
- Tracoe medical GmbH
- Labeler DUNS
- 319414785
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 5
- Public Version Date
- 2024-11-29
- Public Version Status
- Update
- Public Device Record Key
- 70c06f91-a3df-4c9c-b626-1bd9fd37da26
Device Description
Neck Strap
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 |
|---|---|---|---|---|
| CBH | DEVICE, FIXATION, TRACHEAL TUBE | Anesthesiology | 868.5770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35752 | Tracheostomy tube neck holder, reusable | A noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035324064014 | GS1 |
Customer Contacts
- Phone
- +49613691690
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 43.0 | Centimeter | |
| Width | 2.5 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain. Keep away from sunlight.