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Organization name
UDI-DI code
Reference / catalog number

CO2LAP — Class IIb MDD by S.E. Carburos…

MD Atlas
S.E. Carburos Metálicos, S.A.

EUDAMED last updated this device on Dec 20, 2021

CO2LAP

B-08420219100018

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: S.E. Carburos Metálicos, S.A.
UDI-DI code: 08420219100018
Reference / catalog number: CO2LAP

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Manufacturer information

Organization name: S.E. Carburos Metálicos, S.A.
SRN: ES-MF-000003117
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW010
El paciente debe estar monitorizado para detectar posibles casos de embolismo gaseoso. Durante la insuflación de dióxido de carbono en pacientes con EPOC, se debe tener especial cuidado en el control de la función pulmonar y el equilibrio ácidobase debido a que estos pacientes tienen la función pulmonar alterada.
CW060
Gas licuado no inflamable. La exposición prolongada a fuentes de calor puede causar la ruptura y explosión de la botella
CW999
El dióxido de carbono causa asfixia a concentraciones elevadas (ej. en caso de fuga en una atmósfera confinada). Las bajas concentraciones de dióxido de carbono conducen a respiración rápida, dolor de cabeza, náuseas, pérdidas de conocimiento.
CW040
Gas licuado no inflamable. La exposición prolongada a fuentes de calor puede causar la ruptura y explosión de la botella

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Sep 22, 2010	Still on market
Portugal	Sep 22, 2010	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08420219100018
Basic UDI-DI: B-08420219100018
Reference / catalog number: CO2LAP
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CO2 en botellas de 2l a 50l
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0901CLINICAL/THERAPEUTIC APPLICATIONS CARBON DIOXIDE

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

2 HIGH PRESSURE FLEXIBLE CONNECTIONS - AIRB-08420219351236On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - N2-800, CO2B-08420219351267On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - N2OB-08420219351250On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - N2O / REPLACEMENTB-08420219351229On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - O2B-08420219351212On the market

Certificates

Certificate health across this manufacturer's portfolio.

ES24/00000069Issued
Quality management systemNotified body: 1639Expiry: Jan 9, 2029
ES/00000039Issued
Quality management systemNotified body: 1639Expiry: Jan 9, 2029