Identity
- Trade Name
- Deluxe Closed Suction System 72hr FDA UDI
- Generic Name
- Closed-suction breathing circuit connector/switch FDA UDI
- Device Name
- "Deluxe CSS, Adult, 72-hours, Tracheostomy, 305mm, 12Fr, 1-hand switch, with Wedge + Adapte" FDA UDI
- Model / Reference
- VEN368120 FDA UDI
- Description
- "Deluxe CSS, Adult, 72-hours, Tracheostomy, 305mm, 12Fr, 1-hand switch, with Wedge + Adapte" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530095727 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-suction breathing circuit connector/switch 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Closed-suction breathing circuit connector/switch
Deluxe Closed Suction System 72hr by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Closed-suction breathing circuit connector/switch.
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- Resp-O2 Closed Suction Endotracheal Catheters, Sterile — Dynarex Corp. · Class I
- Resp-O2 Closed Suction Tracheostomy Catheters, Sterile — Dynarex Corp. · Class I
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- Resp-O2 Closed Suction Tracheostomy Catheters Sterile — Dynarex Corp. · Class I
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 89b1a9f7-3c15-4bcf-8d9d-09de4e701b7f 34 fields · synced May 30, 2026