Identity
- Trade Name
- TRACOE care FDA UDI
- Generic Name
- Tracheostomy tube neck holder, reusable FDA UDI
- Device Name
- Neck Strap FDA UDI
- Model / Reference
- REF 903-B FDA UDI
- Description
- Neck Strap FDA UDI
Identifiers
- Catalog Number
- REF 903-B FDA UDI
- Primary DI / UDI-DI
- 04035324046911 FDA UDI
- FDA Product Code
- CBH FDA UDI
- GMDN Term
- Tracheostomy tube neck holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 47.0 Centimeter FDA UDIWidth — 2.5 Centimeter FDA UDI
Category: Tracheostomy tube neck holder, reusable
TRACOE care by Tracoe medical GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tracoe medical GmbH
Sources (1)
- FDA UDI fc823421-9817-4449-8001-98f5e49f1dd2 37 fields · synced May 31, 2026