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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

LF135700 — Class IIa MDR by CRYOPAL

MD Atlas
CRYOPAL

EUDAMED last updated this device on Apr 4, 2023

LF135700

376033557FREELOXRESERVEXA

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CRYOPAL
UDI-DI code: 03760335570148
Reference / catalog number: LF135700

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Manufacturer information

Organization name: CRYOPAL
SRN: FR-MF-000003522
Manufacturer status: Active

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760335570148
Basic UDI-DI: 376033557FREELOXRESERVEXA
Reference / catalog number: LF135700
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The home liquid oxygen system is a stationary oxygen tank (FREELOX RESERVE) that can be fitted with a small portable oxygen tank (for example, FREELOX PORTABLE). These are designed to store oxygen in its liquid state at a temperature of -183°C (liquid oxygen is a cryogenic fluid). The FREELOX RESERVE device is a pressurised liquid oxygen tank (20L, 32L or 44L). It is used to continuously deliver a flow rate of gaseous oxygen to a patient.
Additional information URL: https://www.cryopal.com/documentation
Clinical sizes: 32 MU02
0–6000 MU57

EMDN nomenclature code(s)

Z12159099VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER

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

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Certificates

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.