Identity
- Trade Name
- SpiroScout SP FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102 FDA UDI
Identifiers
- Catalog Number
- 013400562 FDA UDI
- Primary DI / UDI-DI
- 04250972300134 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic spirometer, professional
SpiroScout SP by Ganshorn Medizin Electronic GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Alpha — Vitalograph Ireland, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ganshorn Medizin Electronic GmbH
Sources (1)
- FDA UDI 5fbbca51-93b8-4531-afba-20b3fa048b12 36 fields · synced Jun 8, 2026