Identity
- Trade Name
- Vortex FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- Mask, VORTEX, Child Frog FDA UDI
- Model / Reference
- 044F5210 FDA UDI
- Description
- Mask, VORTEX, Child Frog FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00744229440819 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Nebulizing system delivery set, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 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
No
FDA UDI
Over-the-Counter
Yes
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: Nebulizing system delivery set, reusable
Vortex by Pari Respiratory Equipment, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nebulizing system delivery set, reusable.
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- VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
- Portable Mesh Nebulizer — FEELLIFE HEALTH INC. · Class II
- Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
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
- Pari Respiratory Equipment, Inc.
Sources (1)
- FDA UDI c9096c8e-c2a5-4cc3-9d04-b955fce8a24e 33 fields · synced May 31, 2026