Identity
- Trade Name
- Deluxe Closed Suction System FDA UDI
- Generic Name
- Cricothyrotome, single-use FDA UDI
- Device Name
- "Deluxe CSS, Adult, 24-hours, Endotracheal, 540mm, MDI Port, 12Fr,1-hand switch,sterile,latex-free FDA UDI
- Model / Reference
- VEN160120M FDA UDI
- Description
- "Deluxe CSS, Adult, 24-hours, Endotracheal, 540mm, MDI Port, 12Fr,1-hand switch,sterile,latex-free FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530095123 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Cricothyrotome, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Cricothyrotome, single-use
Deluxe Closed Suction System by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cricothyrotome, single-use.
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- Simplified Cricothyrotomy Kit — SAFEGUARD US OPERATING, LLC · Class II
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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI edea8bdb-9a72-445e-b1dd-42a4e9363e14 34 fields · synced Jun 8, 2026