PRISMAFLEX SET

Organization name

Vantive Health GmbH

SRN

CH-MF-000038981

Manufacturer status

Active

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• CW001

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• CW007

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• CW009

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• CW010

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Primary placement in Italy; available across 32 countries total.

Trade name

PRISMAFLEX SET

UDI-DI code

07332414201289

Basic UDI-DI

7332414VA00002835

Reference / catalog number

107142MDR

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://eifu.vantive.com/

Clinical sizes

• 100–450 MU57
• 1.4 MU85
• Blood volume in set — 184 MU48
• Prismaflex HF1000-1400 sets are intended to be used for patients with a body weight greater than 30kg (66lb)
• Maximum blood pressure — 500 MU51

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

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

• F01060303DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES