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Blue Rhino G2-Multi
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref C-PTISYJ-100-HC-G-EU-EVAC8.5Ref C-PTIS-100-HC-G-EU-EVAC8.5
by Cook Ireland
Identity
- Trade Name
- Blue Rhino G2-Multi EUDAMEDBlue Rhino FDA UDI
- Generic Name
- Tracheostomy kit, single-use FDA UDI
- Device Name
- Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set EUDAMEDFDA UDIBlue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray FDA UDI
- Model / Reference
- C-PTISYJ-100-HC-G-EU-EVAC8.5 EUDAMEDC-PTIS-100-HC-G-EU-EVAC8.5 EUDAMEDG57727 FDA UDIG57698 FDA UDI
- Description
- Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray FDA UDIBlue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set FDA UDI
Identifiers
- Catalog Number
- C-PTISYJ-100-HC-G-EU-EVAC8.5 FDA UDIC-PTIS-100-HC-G-EU-EVAC8.5 FDA UDI
- Primary DI / UDI-DI
- 00827002577275 EUDAMEDFDA UDI00827002576988 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002CIRL202203071034CJ EUDAMED
- 510(k) Number
- K193133 FDA UDI
- FDA Product Code
- JOH FDA UDI
- EMDN Code
- R010601 CIAGLIA TRACHEOSTOMY KITS EUDAMED
- GMDN Term
- Tracheostomy kit, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Medical Purpose
- The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set is used to provide mutually compatible medical devices for percutaneous dilatational tracheostomy procedure. EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
Blue Rhino G2-Multi by Cook Ireland Limited — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0827002CIRL202203071034CJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cook Ireland
- EUDAMED SRN
- IE-PR-000002461
Sources (4)
- EUDAMED 6d93dffb-8aef-4482-b02c-89dcd194e73d 61 fields · synced Jul 27, 2026
- FDA UDI e1f4f766-301d-4796-9ccf-c33e858cd911 38 fields · synced May 30, 2026
- FDA UDI c04defd7-060e-4405-897f-accb00d684f2 38 fields · synced May 30, 2026
- EUDAMED ffc69e99-3be7-49c8-a030-47680fc26e27 61 fields · synced Jul 9, 2026