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Organization name
UDI-DI code
Reference / catalog number

Nursing blanket FR&TR Standard… — Class I MDR by Fico bv

MD Atlas
Fico bv

EUDAMED last updated this device on Jun 27, 2023

Nursing blanket FR&TR Standard without sleeves without zip for tube access

5407010900702015L

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fico bv
UDI-DI code: 05407010900002
Reference / catalog number: 070201

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Manufacturer information

Organization name: Fico bv
SRN: BE-MF-000033687
Manufacturer status: Active

Critical warnings

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

CW007
Raadpleeg voor gebruik de gebruiksaanwijzing: Lees voor gebruik de gebruiksaanwijzing.

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: Nursing blanket FR&TR Standard without sleeves without zip for tube access
UDI-DI code: 05407010900002
Basic UDI-DI: 5407010900702015L
Reference / catalog number: 070201
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Het verpleegdeken heeft een permanente brandvertragende eigenschap en het stof is sterk en scheurbestendig. De patiënt ligt rechtstreeks op het bed, onder het verpleegdeken. Vanaf de heupen gaat het verpleegdeken over in een pyjama. De ritssluiting loopt van de kin tot aan het voeteinde van het bed zodat de patiënt niet zelf uit het verpleegdeken kan. Aan de zijkant kan optioneel een ritsopening van 10 cm voorzien worden voor eventuele toegang voor buisjes. Geschikt voor rustige patiënten.
Additional information URL: https://www.ficobelgium.eu/soft-fix/verpleegdekens/verpleegdeken-fire-resist
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

Related devices

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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.