PSC-01

Organization name

Pentracor GmbH

SRN

DE-MF-000010815

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.
• CW001

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• CW007

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• CW032

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• CW262

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Primary placement in Germany; available across 2 countries total.

Trade name

not provided

UDI-DI code

D-4260431430012QB

Basic UDI-DI

B-4260431430012QB

Reference / catalog number

PSC-01

Issuing entity

EUDAMED

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Adsorber for selective removal of C-Reactive Protein (CRP) from human plasma

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Adsorber housing: 88.0 mm x 43.5 mm, Ø 38.0 mm
• for human plasma: ≤ 40 ml/min, for solutions: ≤ 100 ml/min
• Total internal volume of the adsorber housing: 33 ml, volume of CRP-binding matrix: 20 ml
• binding capacity > 300 mg CRP (at full saturation / under laboratory conditions)
• Particel size of the CRP binding matrix: 40 µm - 160 µm

• F01080102IMMUNOADSORPTION COLUMNS

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

This device is not currently linked to any other device.