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Kit, Sample, Agents, 3160
EUDAMEDFDA UDIClass I (EU MDR)
Ref 94018Model Single Use Gas Sampling Line
Identity
- Trade Name
- Kit, Sample, Agents, 3160 EUDAMEDMR Patient Care Kit, Sample, Agents, 3160 FDA UDI
- Generic Name
- Exhaled-gas sample collector, non-electronic FDA UDI
- Device Name
- Single Use Gas Sampling Line EUDAMEDKIT,SAMPLE,AGENTS,3160 FDA UDI
- Model / Reference
- Single Use Gas Sampling Line EUDAMED94018 EUDAMEDKit, Sample, Agents, 3160 FDA UDI
- Description
- KIT,SAMPLE,AGENTS,3160 FDA UDI
Identifiers
- Catalog Number
- 94018 FDA UDI
- Primary DI / UDI-DI
- 00884838120563 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1075M8 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Exhaled-gas sample collector, non-electronic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Austria 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
Kit, Sample, Agents, 3160 by Philips Medizin Systeme Böblingen GmbH — 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 | 0884838BM1075M8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 1377eee0-1b2e-499b-bc97-166d8b831164 61 fields · synced Jun 18, 2026
- FDA UDI 7127daa5-5d80-4e2f-8017-9e62842ffd13 35 fields · synced May 30, 2026