Identity
- Trade Name
- Patient Spirometry Tubes EUDAMEDNA FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Patient Spirometry Tubes EUDAMEDSpirometry Tube, disposable, 6m/20ft EUDAMEDFDA UDI
- Model / Reference
- 891191-HEL EUDAMEDSpirometry Tube, disposable, 6m/20ft FDA UDI
- Description
- SPIROMETRY TUBE, DISPOSABLE, 6M/20FT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103619 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004797T EUDAMEDB-00840682103619 EUDAMED
- FDA Product Code
- NHQ FDA UDICCL FDA UDINHO FDA UDICBQ FDA UDICAP FDA UDICBR FDA UDIBZL FDA UDICBS FDA UDINHP FDA UDIBZK 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 I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1500 FDA UDI868.1720 FDA UDI868.2600 FDA UDI868.1700 FDA UDI868.1730 FDA UDI868.1620 FDA UDI868.1850 FDA UDI868.1400 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose multi-parameter bedside monitor
Patient Spirometry Tubes by GE Healthcare Finland Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08406821BUG004797T | Class I | Active |
| EUDAMED | European Union | CE/MDD | 08406821BUG004797T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (3)
- EUDAMED dbc8a127-3c7f-4ece-86de-803237a8c258 61 fields · synced Oct 7, 2026
- EUDAMED ff827b47-983a-4af1-bc28-dff08f6dada9 61 fields · synced May 17, 2026
- FDA UDI 72159bf6-41eb-476c-b9a5-eb163b22369c 34 fields · synced May 29, 2026