Pressure reducer N2O, PININDEX, Primus
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Dminderer N2O,PININDEX,Primus EUDAMEDPressure reducer N2O,PININDEX,Primus FDA UDI
- Generic Name
- Anaesthesia workstation yoke assembly FDA UDI
- Model / Reference
- 8603462 EUDAMEDFDA UDI308020XK19X010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675290292 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751308020XK19X010CA EUDAMED
- Direct Marketing DI
- 04048675290292 EUDAMED
- FDA Product Code
- CAN FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Anaesthesia workstation yoke assembly FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 868.2700 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
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
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
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Anaesthesia workstation yoke assembly
Pressure reducer N2O, PININDEX, Primus by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia workstation yoke assembly.
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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 aed13a4a-93d1-4079-b12b-c2cff4180c35 32 fields · synced Oct 7, 2026
- EUDAMED a8c93f4c-4ae7-4a39-a079-0c475b359d52 61 fields · synced Jul 9, 2026