Organization name

OXYVEIN BASINC TEKNOLOJILERI ITHALAT IHRACAT SANAYI VE TICARET ANONIM SIRKETI SUBESI

SRN

TR-MF-000042315

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• It is an untreatedpneumothorax due to the possibility of transforming it into atension pneumothorax as the intra-pleural air expandsduring decompression. Elective treatment withHBO is contraindicated in patients with a very distanthistory of bleomycin administration. However, inemergency, life-threatening situations, the benefits of HBOmay outweigh the possibility of bleomycin toxicity. Doxorubicin: In animals,concurrent administration of HBO with doxorubicin hasbeen associated with cardiac toxicity. Disulfram may block theproduction of superoxide dismutase, resulting in decreased free radical scavenging in hyperbaric environments. Mafenide Acetate(Sulfamylin) Increases the likelihood of oxygen toxicityseizures. Emphysema containmentwith CO2 Risk of blunting of the hypoxic respiratory driveand/or rupture of the bubble during ascent leading topneumothorax. Upper respiratory tractinfections or chronic sinusitis These conditions can makeclearing the ears difficult and/or cause significant sinuscompression. Seizure disorder Increasedrisk of oxygen-induced seizures.

  OTHER

Primary placement in Türkiye; available across 32 countries total.

Trade name

OXYVEIN

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08684718927433

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-08684718927433

Reference / catalog number

OXYMULTI 2+2S

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z120308HYPERBARIC CHAMBERS

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.