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LoFlo SAMPLING LINE KIT w/Dehumidification Tubing
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3475-00
Identity
- Trade Name
- LoFlo SAMPLING LINE KIT w/Dehumidification Tubing EUDAMEDLoFlo FDA UDI
- Generic Name
- Gas dehumidification tubing set, single-use FDA UDI
- Device Name
- CO2 Sampling Line EUDAMEDLoFlo SAMPLING LINE KIT w/Dehumidification Tubing FDA UDI
- Model / Reference
- 3475-00 EUDAMEDFDA UDI
- Description
- LoFlo SAMPLING LINE KIT w/Dehumidification Tubing FDA UDI
Identifiers
- Catalog Number
- 3475-00 FDA UDI
- Primary DI / UDI-DI
- 00884838013926 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM736TJ EUDAMED
- FDA Product Code
- CCK FDA UDI
- EMDN Code
- Z1203020485 GASEOUS EXCHANGE MONITORING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Gas dehumidification tubing set, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
LoFlo SAMPLING LINE KIT w/Dehumidification Tubing by Respironics Novametrix, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0884838BM736TJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Novametrix, LLC
- EUDAMED SRN
- US-MF-000007951
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 38673030-1280-465b-a7fe-c0dadcdc62d8 61 fields · synced Oct 6, 2026
- FDA UDI 50513ea8-3161-4303-b81c-2e35066b7f14 36 fields · synced May 30, 2026