- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Aug 1, 2023
5904169486azotmedycznyQ2MedLIN Ciekły azot medyczny is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Air Liquide Polska Sp. z o.o. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
59041694860002None(01)59041694860002
European Medical Device Nomenclature — the EU product classification assigned to this device.
V0902CLINICAL/THERAPEUTIC APPLICATIONS LIQUID NITROGEN10 warnings recorded — scroll inside the panel to see all entries.
Due to the extremely low temperature of medical nitrogen, frostbite and damage to body surfaces can occur if handled incorrectly.
Even brief exposure to liquid medical nitrogen and its fumes can lead to frostbite of the ocular surface, irreversible damage and even blindness.
If symptoms of hypoxia, suffocation occur, move the the affected person to another room free fromexcessive nitrogen concentration and then call a doctor.
A person exposed to high concentrations of nitrogen may not be aware that they are suffocating. Note: Symptoms of asphyxiation can be difficult to ascertain. Early signs of hypoxia include restlessness, confusion and agitation. W the next stage there may be loss of motor skills/consciousness. consciousness.
Primary placement in Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Jul 10, 2018 | Dec 31, 2028 |
PL-MF-000007135The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Accidental prolonged inhalation of vapours or aerosol of cold nitrogen may cause irritation, swelling and burns of the mouth throat, bronchi or lungs.
Due to the physical properties, personnel in contact with medical liquid nitrogen should take particular caution,use eye, upper respiratory and face protection, use protective gloves against cold, protective clothing protective clothing (e.g. cryogenic apron) and enclosed footwear.
If symptoms of hypoxia, suffocation occur, move the the affected person to another room free fromexcessive nitrogen concentration and then call a doctor.
In case of accidental ingestion of liquid nitrogen medical, a doctor should be contacted immediately.
If worrying symptoms occur, contact a doctor.
If liquid medical nitrogen comes into contact with the eyes, immediately flush the eyes with lukewarm water at a at a temperature of approximately 37°C for at least 15 minutes.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
This device is not currently linked to any other device.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.