ErgoStar CM 40
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- ErgoStar CM 40 EUDAMEDFDA UDI
- Generic Name
- Straight/elbow breathing circuit connector, single-use FDA UDI
- Model / Reference
- MP01840 EUDAMEDFDA UDI2080076K19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675420736 EUDAMED04048675042624 FDA UDI
- Basic UDI-DI
- 0404867512080076K19Z000ST EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R020202 MOBILE CATHETER MOUNTS EUDAMED
- GMDN Term
- Straight/elbow breathing circuit connector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 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: Straight/elbow breathing circuit connector, single-use
ErgoStar CM 40 by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Straight/elbow breathing circuit connector, single-use.
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- CONNECTOR 15M-10F — Intersurgical Incorporated · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- AirLife™ — Airlife, Inc. · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- 15 mm Adaptor — Boston Medical Products, Inc. · Class II
- AirLife™ — Airlife, Inc. · Class I
- AirLife™ — Airlife, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 7b58eb1d-b6be-4a13-95ab-e867555a8aa3 33 fields · synced Jul 14, 2026
- EUDAMED e3126477-f7c2-420c-bed0-e75fec3824ce 61 fields · synced Jul 14, 2026