Identity
- Trade Name
- AeroEclipse* BAN* FDA UDI
- Generic Name
- Breathing mouthpiece, reusable FDA UDI
- Device Name
- AE II BAN with EZ Twist Tubing & Filtered Mouthpiece Kit, cs/25 FDA UDI
- Model / Reference
- AE II BAN & Filtered Mouthpiece, cs/25 FDA UDI
- Description
- AE II BAN with EZ Twist Tubing & Filtered Mouthpiece Kit, cs/25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00604351602250 FDA UDI
- 510(k) Number
- K220145 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Breathing mouthpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breathing mouthpiece, reusable
AeroEclipse* BAN* by Monaghan Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing mouthpiece, reusable.
- Winx® — Apnicure, Inc. · Class II
- Vyaire — Jaeger Medical GmbH · Class I
- Mouthpiece — SDI DIAGNOSTICS, INC. · Class II
- Vyaire — Jaeger Medical GmbH · Class I
- BF — Allied Medical LLC · Class I
- Itus Mouthguardz — SHINRIN-YOKU TRADERS LLC · Class II
- Adapter, Tube, Sample Pack — A-M Systems, Inc. · Class I
- Vyaire — Jaeger Medical GmbH · Class I
Cleared under the same submission
K220145 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Monaghan Medical Corp.
Sources (1)
- FDA UDI 3231ff6a-9b13-4c8f-bee3-d0bf288b1a70 35 fields · synced May 30, 2026