Identity
- Trade Name
- AVEA FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- SPECTRA MAX PRESSURE OPTN CRYP FDA UDI
- Model / Reference
- 776142 FDA UDI
- Description
- SPECTRA MAX PRESSURE OPTN CRYP FDA UDI
Identifiers
- Catalog Number
- 776142 FDA UDI
- Primary DI / UDI-DI
- 10190752164055 FDA UDI
- 510(k) Number
- K942211 FDA UDI
- FDA Product Code
- BTY FDA UDI
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function analysis system, adult
Avea by Vyaire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function analysis system, adult.
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- VISCOFLU — PHARMA LINE Srl · Class IIb
- Volume Calibration Syringe — HANS RUDOLPH, INC. · Class I
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
Cleared under the same submission
K942211 also covers:
- Avea — VYAIRE MEDICAL, INC.
- Avea — VYAIRE MEDICAL, INC.
- FreeFlow™ — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, INC.
- VMAX — VYAIRE MEDICAL, 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
- Vyaire Medical, Inc.
Sources (1)
- FDA UDI 384de3b4-ba32-4920-935d-9b33f9624b36 36 fields · synced Jun 8, 2026