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Control Devices
EUDAMEDFDA UDIClass IIb (EU MDD (legacy))
Ref 1539113800-3Model 1539113800
Identity
- Trade Name
- Control Devices EUDAMEDFDA UDI
- Generic Name
- FLOW REGULATORS EUDAMEDNon-fixed medical gas cylinder regulator FDA UDI
- Device Name
- CGA 870 Regulator EUDAMEDCGA 870 EMS Oxygen Regulator, 50 psig, Barbed Outlet, Nickel-plated brass Body, 0-25 L/min, 2 DISS 1240 Auxiliary Ports FDA UDI
- Model / Reference
- 1539113800 EUDAMEDFDA UDI1539113800-3 EUDAMED
- Description
- CGA 870 EMS Oxygen Regulator, 50 psig, Barbed Outlet, Nickel-plated brass Body, 0-25 L/min, 2 DISS 1240 Auxiliary Ports FDA UDI
Identifiers
- Catalog Number
- 1539113800-3 FDA UDI
- Primary DI / UDI-DI
- 00810051632286 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810051632286 EUDAMED
- FDA Product Code
- CAN FDA UDI
- EMDN Code
- A030104 FLOW REGULATORS EUDAMED
- GMDN Term
- Non-fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Legislation / Framework
- MDD (Directive 93/42/EEC on Medical Devices) EUDAMED
- Regulation Number
- 868.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Control Devices by Control Devices, LLC (flow regulators) — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00810051632286 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Control Devices, LLC
- EUDAMED SRN
- US-MF-000038165
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED cfc0a0b7-e75b-4cf1-bc48-7ee210f9de7f 68 fields · synced May 30, 2026
- FDA UDI f2fb0a1b-59c1-4793-97e3-d09a28282209 34 fields · synced May 30, 2026