Inf.ID Breath.CircuitSm. 300
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Inf.ID Atemschl. in.glatt 300 EUDAMEDInf.ID Breath.CircuitSm. 300 FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Model / Reference
- MP04804 EUDAMEDFDA UDI2080456K19P020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675635307 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867512080456K19P020SZ EUDAMED
- FDA Product Code
- CAI FDA UDIBZO FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI868.5975 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Anaesthesia breathing circuit, single-useVentilator breathing circuit, single-use
Inf.ID Breath.CircuitSm. 300 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 2e0a7b5a-1c65-4d44-9a15-5b61c196a6ec 32 fields · synced Jul 20, 2026
- EUDAMED 9513faff-f589-49b6-b6a8-f16789e921a7 61 fields · synced Jul 20, 2026