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Spirometry Tube, disposable, 2m/7ft
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 890031
Identity
- Trade Name
- Patient Spirometry Tubes EUDAMEDNA FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Spirometry Tube, disposable, 2m/7ft EUDAMEDFDA UDIPatient Spirometry Tubes EUDAMED
- Model / Reference
- 890031 EUDAMEDSpirometry Tube, disposable, 2m/7ft FDA UDI
- Description
- SPIROMETRY TUBE, DISPOSABLE, 2M/7FT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103701 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682103701 EUDAMED08406821BUG004797T EUDAMED
- FDA Product Code
- CBS FDA UDICCL FDA UDICBQ FDA UDIBZK FDA UDICBR FDA UDICAP FDA UDINHO FDA UDINHP FDA UDIBZL FDA UDINHQ FDA UDICCK FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1620 FDA UDI868.1720 FDA UDI868.1500 FDA UDI868.1850 FDA UDI868.1700 FDA UDI868.2600 FDA UDI868.1730 FDA UDI868.1400 FDA UDI
- Market of Registration
- Finland 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Spirometry Tube, disposable, 2m/7ft by GE Healthcare Finland Oy — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840682103701 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00840682103701 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (3)
- EUDAMED ac84eb45-728b-4cf7-8a2a-9a2d2eb2cfc1 61 fields · synced Oct 6, 2026
- EUDAMED ce0a9774-f5b2-4fd4-b389-d6769eeee61a 61 fields · synced May 18, 2026
- FDA UDI d408db5d-26de-4af3-8abc-9e5445778908 34 fields · synced May 30, 2026