Identity
- Trade Name
- Bubble Humidifier FDA UDI
- Generic Name
- Non-heated respiratory humidifier FDA UDI
- Device Name
- Bubble Humidifier FDA UDI
- Model / Reference
- PN-302-01 FDA UDI
- Description
- Bubble Humidifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872103028 FDA UDI
- FDA Product Code
- KFZ FDA UDI
- GMDN Term
- Non-heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5460 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: Non-heated respiratory humidifier
Bubble Humidifier by Enter Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-heated respiratory humidifier.
- Bubble Humidifier — WESTMED, INC. · Class I
- SENSIMEDICAL Sterile Water for Inhalation, USP — Sensimedical LLC · Class II
- NanoVi — Eng3 Corporation · Class I
- B&F — Allied Medical LLC · Class II
- Bubble Humidifier — WESTMED, INC. · Class I
- B&F — Allied Medical LLC · Class II
- Chemtron — Allied Medical LLC · Class II
- Procure — Twin Med, LLC · 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
- Enter Medical Corporation
Sources (1)
- FDA UDI c300f4e4-397d-4863-af93-c57e88b6d32e 33 fields · synced May 30, 2026