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Y-PIECE evita
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 8405435Model 208044PK19T020
Identity
- Trade Name
- Y-Stueck EUDAMEDY-PIECE evita FDA UDI
- Generic Name
- Y-piece breathing circuit connector, reusable FDA UDI
- Model / Reference
- 8405435 EUDAMEDFDA UDI208044PK19T020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675012337 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208044PK19T020A4 EUDAMED
- Direct Marketing DI
- 04048675012337 EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R020302 RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS EUDAMED
- GMDN Term
- Y-piece breathing circuit connector, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Y-PIECE evita by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 352c2546-7807-4565-93d2-58084faf7cce 33 fields · synced Oct 6, 2026
- EUDAMED 16dba38e-a892-4190-b1b5-75fafc56df64 61 fields · synced Sep 17, 2026