# B.braun 7102230

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/b-braun-7102230>
- Manufacturer: [B.Braun Avitum AG](https://devicerts.com/manufacturers/b-braun-avitum-ag) (Germany)
- Name in the registry: B.BRAUN 7102230
- Device class: Class II (US FDA)
- FDA product code: KDI
- GMDN: Haemodialysis system, institutional (58130)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 04046963686734 · listed 2015-08-09 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K083460 · decision 2010-02-18 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K963440 · decision 1998-06-26 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0872-2022 · Class II · terminated · initiated 2022-01-28: Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
- Z-0873-2022 · Class II · terminated · initiated 2022-01-28: Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
- Z-1532-2016 · Class I · terminated · initiated 2016-04-01: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Z-1535-2016 · Class I · terminated · initiated 2016-04-01: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Z-1531-2016 · Class I · terminated · initiated 2016-04-01: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Z-1536-2016 · Class I · terminated · initiated 2016-04-01: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Z-1533-2016 · Class I · terminated · initiated 2016-04-01: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- Z-1534-2016 · Class I · terminated · initiated 2016-04-01: Potential leakage of conductivity sensors of the Dialog Dialysis machines.

## Identity

- Trade name: B.BRAUN [FDA GUDID (AccessGUDID)]
- Generic name: Haemodialysis system, institutional [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 7102230 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04046963686734 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K083460 [FDA GUDID (AccessGUDID)]; K963440 [FDA GUDID (AccessGUDID)]
- FDA product code: KDI [FDA GUDID (AccessGUDID)]
- GMDN term: Haemodialysis system, institutional (58130) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 876.5860 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: B.braun 7102230, B.Braun Avitum AG. deviCERTS medical device catalogue. https://devicerts.com/devices/b-braun-7102230 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/b-braun-7102230.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/b-braun-7102230
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.