Identity
- Trade Name
- Vortex FDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- Vortex Nonelectrostatic Holding Chamber, custom label FDA UDI
- Model / Reference
- 051F7500 FDA UDI
- Description
- Vortex Nonelectrostatic Holding Chamber, custom label FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00744229510437 FDA UDI
- 510(k) Number
- K020944 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Medicine chamber spacer, 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
No
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: Medicine chamber spacer, reusable
Vortex by Pari Respiratory Equipment, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medicine chamber spacer, reusable.
- Antistatic Compact Space Chamber — Medical Developments International · Class II
- LiteTouch — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- Drive — Drive Devilbiss Healthcare · Class II
- Aerochamber Plus® Z STAT® — MONAGHAN MEDICAL CORP. · Class II
- AeroChamber Plus® Flow-Vu® — MONAGHAN MEDICAL CORP. · Class II
- 1A CHAMBER — PATEJIM S.R.L. · Class I
- OptiChamber Diamond — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
- BREATHE COMFORT — Slv Pharmaceuticals LLC · Class II
Cleared under the same submission
K020944 also covers:
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
- Vortex — PARI RESPIRATORY EQUIPMENT, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pari Respiratory Equipment, Inc.
Sources (1)
- FDA UDI b42e60b2-a48c-4aa7-bb0f-eda0a7f5fcab 34 fields · synced May 30, 2026