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Gas Sampling Line, disposable, PVC/PE, 6m/20ft
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2097307-003
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Gas-sampling/monitoring respiratory tubing, single-use FDA UDI
- Device Name
- Gas Sampling Line, disposable, PVC/PE, 6m/20ft EUDAMEDGAS SAMPLING LINE, DISPOSABLE, PVC/PE, 6M/20FT, 1 PCS FDA UDI
- Model / Reference
- 2097307-003 EUDAMEDFDA UDI
- Description
- GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 6M/20FT, 1 PCS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682120685 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682120685 EUDAMED
- FDA Product Code
- CBQ FDA UDICCL FDA UDINHQ FDA UDIBZL FDA UDINHP FDA UDIBZK FDA UDINHO FDA UDICBS FDA UDICAP FDA UDICBR 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
- 868.1500 FDA UDI868.1720 FDA UDI868.1730 FDA UDI868.1850 FDA UDI868.1620 FDA UDI868.2600 FDA UDI868.1700 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: General-purpose multi-parameter bedside monitor
Gas Sampling Line, disposable, PVC/PE, 6m/20ft by GE Healthcare Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682120685 | 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 eb0258a6-0900-4172-9253-5b784f90176e 61 fields · synced Oct 7, 2026
- FDA UDI 81e047cc-924c-4460-baf4-c7344ea789cd 34 fields · synced May 30, 2026