# Bci 1128

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

- Canonical page: <https://devicerts.com/devices/bci-1128>
- Manufacturer: [ICU Medical, Inc.](https://devicerts.com/manufacturers/icu-medical-inc) (United States)
- Name in the registry: BCI 1128
- Device class: Class II (US FDA)
- FDA product code: CCK
- GMDN: Intravenous administration tubing extension set (12170)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 35019517053627 · listed 2016-10-13 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K991086 · decision 1999-06-09 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0920-2010 ·  · terminated · initiated 2010-01-15: Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq

## Identity

- Trade name: BCI [FDA GUDID (AccessGUDID)]
- Generic name: Intravenous administration tubing extension set [FDA GUDID (AccessGUDID)]
- Model / reference: 1128 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 35019517053627 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K991086 [FDA GUDID (AccessGUDID)]
- FDA product code: CCK [FDA GUDID (AccessGUDID)]
- GMDN term: Intravenous administration tubing extension set (12170) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 868.1400 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before 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)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Bci 1128, ICU Medical, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/bci-1128 (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: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/bci-1128.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/bci-1128
- 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.