Identity
- Trade Name
- Water Trap FDA UDI
- Generic Name
- Breathing circuit condensate trap, single-use FDA UDI
- Device Name
- A non-sterile device intended to be integrated within a breathing circuit FDA UDI
- Model / Reference
- ENT-2013 FDA UDI
- Description
- A non-sterile device intended to be integrated within a breathing circuit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872104124 FDA UDI
- FDA Product Code
- BYH FDA UDI
- GMDN Term
- Breathing circuit condensate trap, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5995 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
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
Category: Breathing circuit condensate trap, single-use
Water Trap by Enter Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing circuit condensate trap, single-use.
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class I
- Resp-O2 Disposable Water Trap, Pediatric, Y Cap, 15 mm, OD Tubing Connector — Dynarex Corp. · Class I
- ProCure — Twin Med, LLC · Class I
- Vital Signs™ — Airlife, Inc. · Class II
- 3100A HFOV — VYAIRE MEDICAL, INC. · Class III
- BF — Allied Medical LLC · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · 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
- Enter Medical Corporation
Sources (1)
- FDA UDI 45b9080f-e4a1-40c9-a522-1b5701fe82db 33 fields · synced Jun 8, 2026