D-lite+ Spirometry Kit, adult, 2m/7ft
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- D-lite+ Spirometry Kit, adult, 2m/7ft EUDAMEDD-LITE+ SPIROMETRY KIT 2 M/7 FT, 8004381 FDA UDI
- Model / Reference
- 8004381 EUDAMEDD-lite Spirometry Kit 2m 7ft, 8004381 FDA UDI
- Description
- D-LITE+ SPIROMETRY KIT 2 M/7 FT, 8004381 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682102872 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682102872 EUDAMED
- FDA Product Code
- CAP FDA UDICBR FDA UDICBQ FDA UDINHO FDA UDIBZL FDA UDINHP FDA UDIBZK FDA UDINHQ FDA UDICBS FDA UDICCL 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 II FDA UDI
- Regulation Number
- 868.2600 FDA UDI868.1700 FDA UDI868.1500 FDA UDI868.1730 FDA UDI868.1850 FDA UDI868.1620 FDA UDI868.1720 FDA UDI868.1400 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
D-lite+ Spirometry Kit, adult, 2m/7ft by GE Healthcare Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682102872 | 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 (2)
- EUDAMED 5036ee60-e9ae-444f-8adc-3fb90d039918 61 fields · synced Oct 6, 2026
- FDA UDI 9a613d2d-6642-47ca-8a2c-dccfa5760022 35 fields · synced May 30, 2026