Identity
- Trade Name
- Ciaglia Blue Rhino FDA UDI
- Generic Name
- Tracheostomy kit, single-use FDA UDI
- Device Name
- Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Tray FDA UDI
- Model / Reference
- G13166 FDA UDI
- Description
- Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Tray FDA UDI
Identifiers
- Catalog Number
- C-PTISY-100-HC-PERC6 FDA UDI
- Primary DI / UDI-DI
- 00827002131668 FDA UDI
- FDA Product Code
- JOH FDA UDI
- GMDN Term
- Tracheostomy kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ciaglia Blue Rhino by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 4b8d79bf-670d-4bbd-872e-d30900ed0ab9 37 fields · synced Jun 8, 2026