Identity
- Trade Name
- Spiration Valve System FDA UDI
- Generic Name
- Endobronchial airway sizing kit FDA UDI
- Device Name
- Airway Sizing Kit FDA UDI
- Model / Reference
- HUS-VSK FDA UDI
- Description
- Airway Sizing Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00896506002217 FDA UDI
- PMA Number
- H060002 FDA UDI
- FDA Product Code
- OAZ FDA UDI
- GMDN Term
- Endobronchial airway sizing kit FDA UDI
Classification
- Device Class
- Unclassified FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endobronchial airway sizing kit
Spiration Valve System by Gyrus Acmi, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endobronchial airway sizing kit.
- Spiration Valve System — Gyrus Acmi, Inc. · Unclassified
- Spiration Valve System — Gyrus Acmi, Inc. · Class III
Cleared under the same submission
H060002 also covers:
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 Unclassified | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI f72dc8d8-f59f-4820-9923-0182622df0d3 34 fields · synced May 30, 2026