Identity
- Trade Name
- Vortex FDA UDI
- Generic Name
- Medicine chamber spacer, reusable FDA UDI
- Device Name
- Vortex Nonelectrostatic Holding Chamber FDA UDI
- Model / Reference
- 051F7000 FDA UDI
- Description
- Vortex Nonelectrostatic Holding Chamber FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00744229510352 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
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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 |
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Manufacturer
- Manufacturer
- Pari Respiratory Equipment, Inc.
Sources (1)
- FDA UDI 865c5b8e-a015-43dc-8e53-21ec6baa62d7 34 fields · synced Jun 1, 2026