# Exactamix H938901

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

- Canonical page: <https://devicerts.com/devices/exactamix-h938901>
- Manufacturer: [Baxter Healthcare Corp](https://devicerts.com/manufacturers/baxter-healthcare-corp) (United States, FDA 510(k) applicant)
- Name in the registry: EXACTAMIX H938901
- Device class: Class II (US FDA)
- FDA product code: KPE
- GMDN: Intravenous administration bag/bottle (35127)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00085412477466 · listed 2016-09-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K960581 · decision 1996-04-30 · decision SESE · status: Active · from GUDID

## Recalls

- Z-0002-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-0008-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-0005-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-0001-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-0007-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-0003-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-0004-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-0006-2020 · Class II · ongoing · initiated 2018-09-21: Potential for leaking product
- Z-2263-2016 · Class II · terminated · initiated 2016-06-23 · matched through shared submission K960581, may concern other models: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

## Identity

- Trade name: EXACTAMIX [FDA GUDID (AccessGUDID)]
- Generic name: Intravenous administration bag/bottle [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: H938901 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00085412477466 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K960581 [FDA GUDID (AccessGUDID)]
- FDA product code: KPE [FDA GUDID (AccessGUDID)]
- GMDN term: Intravenous administration bag/bottle (35127) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 880.5025 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Total Volume — 1500 Milliliter [FDA GUDID (AccessGUDID)]

## Properties

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

## Source and citation

- Cite as: Exactamix H938901, Baxter Healthcare Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/exactamix-h938901 (data as of 2026-11-14).
- 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: 2026-11-14
- JSON: <https://devicerts.com/devices/exactamix-h938901.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/exactamix-h938901
- 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.