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AirLife™ Volumetric Incentive Spirometer 2500ml
EUDAMEDFDA UDIClass I (EU MDR)
Ref 001904A-CEModel Volume Incentive Spirometers
by SunMed
Identity
- Trade Name
- AirLife™ Volumetric Incentive Spirometer 2500ml EUDAMEDAirLife™ FDA UDI
- Generic Name
- Incentive spirometer FDA UDI
- Device Name
- AirLife™ Volumetric Incentive Spirometer 2500ml FDA UDI
- Model / Reference
- Volume Incentive Spirometers EUDAMED001904A-CE EUDAMEDFDA UDI
- Description
- AirLife™ Volumetric Incentive Spirometer 2500ml FDA UDI
Identifiers
- Catalog Number
- 001904A-CE FDA UDI
- Primary DI / UDI-DI
- 30889483642324 EUDAMED10889483642320 FDA UDI
- Basic UDI-DI
- 0889483TF20042aSpiroKF EUDAMED
- Unit of Use DI
- 10889483642320 EUDAMED
- 510(k) Number
- K791819 FDA UDI
- FDA Product Code
- BWF FDA UDI
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
- GMDN Term
- Incentive spirometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
AirLife™ Volumetric Incentive Spirometer 2500ml by SunMed — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889483TF20042aSpiroKF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SunMed
- EUDAMED SRN
- US-MF-000009164
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 4047f7c9-6c42-4a14-abd4-b6616f5103b2 61 fields · synced Jul 31, 2026
- FDA UDI 181b90c7-0624-411c-b76d-2dba2af54758 36 fields · synced May 29, 2026