Allmed SafeFlow

Organization name

Allmed Medical GmbH

SRN

DE-MF-000007862

Manufacturer status

Active

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• CW999

  Contraindications: The utilization of the bacterial and endotoxin filter, manufactured using Polysulfone and PVP, and sterilized by ETO or Gamma and intended to be used for preparation of Ultrapure dialysis fluid and/or online fluid substitution, is contraindicated in individuals with a documented history of hypersensitivity or allergic reactions to any components of the filter, including Polysulfone, PVP, or the sterilization agents ETO and Gamma. Additionally, caution should be exercised in cases where specific contraindications to ETO or Gamma sterilization methods exist for the intended application. Use of the bacterial and endotoxin filter is contraindicated in cases of known hypersensitivity or allergic reactions to Polysulfone, PVP, ethylene oxide (ETO), or Gamma sterilization. Relative contraindications (individual Benefit/Risk to be determined by treating physician) for the use of SafeFlow include: Patients with known hypersensitivity to any of the materials used must not be treated with this product.

Primary placement in EL; available across 1 country total.

Trade name

Allmed SafeFlow

UDI-DI code

04260157725263

Basic UDI-DI

426015772SAFEFLOWEOXQ

Reference / catalog number

SFL 14

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Allmed SafeFlow, is intended to be used for the purification of final dialysate solution to prepare ultrapure dialysis fluid, or the on-line preparation of sterile substitution fluid (in combination with an additional filter; It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis). Purification is achieved through the high bacterial and endotoxin retention capabilities of the filter. Ethylene oxide (EO) sterilized, suitable for connection with B. Braun B.Dialog and B.Dialog+ machine

Additional information URL

https://allmedgroup.com/e-ifu-repository/

Clinical sizes

• 1.4 MU85

• F01080201ENDOTOXIN REMOVAL FILTERS

• Batch number
• Expiration date
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• Software identification