Identity
- Trade Name
- Blue Rhino FDA UDI
- Generic Name
- Tracheostomy kit, single-use FDA UDI
- Device Name
- Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set FDA UDI
- Model / Reference
- G57694 FDA UDI
- Description
- Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set FDA UDI
Identifiers
- Catalog Number
- C-PTIS-100-HC-G-NA-EVAC8.5 FDA UDI
- Primary DI / UDI-DI
- 00827002576940 FDA UDI
- 510(k) Number
- K193133 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
- 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
No
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
Category: Tracheostomy kit, single-use
Blue Rhino by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy kit, single-use.
- Centurion — Centurion Medical Products · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- Portex — ICU MEDICAL, INC. · Class II
- Centurion — Centurion Medical Products · Class I
- Centurion — Centurion Medical Products · Class I
- Centurion — Centurion Medical Products · Class I
- Portex — ICU MEDICAL, INC. · Class II
- Centurion — Centurion Medical Products · Class I
Cleared under the same submission
K193133 also covers:
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
- Blue Rhino — COOK INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 38dae7c4-cc74-45bd-b693-523b1df4c692 37 fields · synced Jun 8, 2026