Identity
- Trade Name
- Convenience Kit FDA UDI
- Generic Name
- Breathing circuit condensate trap, reusable FDA UDI
- Device Name
- Adult Heated Passive Circuit Based On OEM 1076046 - VEN002+VC1114 FDA UDI
- Model / Reference
- AIND004HPC FDA UDI
- Description
- Adult Heated Passive Circuit Based On OEM 1076046 - VEN002+VC1114 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530096168 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Breathing circuit condensate trap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Breathing circuit condensate trap, reusable
Convenience Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing circuit condensate trap, reusable.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- WaterLock2 — Drägerwerk AG & Co. KGaA · Class I
- WT 250 Water Trap — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
- Expression MR KIT, DISPOSABLE WATER TRAP, 3160 — Philips DS North America LLC · Class II
- HG 100 Humidifier Guard — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Composite Respiratory Kit: Nationwide Medical — WESTMED, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 1f1e1e1e-45c9-4353-af30-43387f050d29 34 fields · synced May 31, 2026