Infinity ID Flow Sensor
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Infinity ID Flowsensor (5x) EUDAMEDInfinity ID Flow Sensor FDA UDI
- Generic Name
- Breathing circuit gas-flow sensor, reusable FDA UDI
- Model / Reference
- 6871980 EUDAMEDFDA UDI301011XK19P010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675448938 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751301011XK19P01029 EUDAMED
- Direct Marketing DI
- 04048675448938 EUDAMED
- FDA Product Code
- BXP FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Breathing circuit gas-flow sensor, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2885 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Breathing circuit gas-flow sensor, reusable
Infinity ID Flow Sensor by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI cea0d638-6f26-4bec-8636-795d5a1d8b26 32 fields · synced Aug 3, 2026
- EUDAMED eb60df8a-5b91-40e2-a9e8-0b9e14bdbf17 61 fields · synced Aug 3, 2026