# DiamondTemp™ Irrigation Pump CEDTP100

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

- Canonical page: <https://devicerts.com/devices/diamondtemp-irrigation-pump-cedtp100>
- Manufacturer: [Medtronic, Inc.](https://devicerts.com/manufacturers/medtronic-inc) (United States)
- Device class: Class III (US FDA)
- FDA product code: OAE
- GMDN: Basic roller pump (36664)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00763000482145 · listed 2021-10-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA PMA · United States · P200028 · decision 2021-01-28 · decision APPR · status: Active · from GUDID

## Recalls

- Z-1320-2021 · Class II · ongoing · initiated 2021-02-22: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- Z-1318-2021 · Class II · ongoing · initiated 2021-02-22: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- Z-1317-2021 · Class II · ongoing · initiated 2021-02-22: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- Z-1322-2021 · Class II · ongoing · initiated 2021-02-22: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- Z-1319-2021 · Class II · ongoing · initiated 2021-02-22: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.
- Z-1321-2021 · Class II · ongoing · initiated 2021-02-22: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

## Identity

- Trade name: DiamondTemp™ Irrigation Pump [FDA GUDID (AccessGUDID)]
- Generic name: Basic roller pump [FDA GUDID (AccessGUDID)]
- Model / reference: CEDTP100 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00763000482145 [FDA GUDID (AccessGUDID)]
- PMA number: P200028 [FDA GUDID (AccessGUDID)]
- FDA product code: OAE [FDA GUDID (AccessGUDID)]
- GMDN term: Basic roller pump (36664) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

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

## Source and citation

- Cite as: DiamondTemp™ Irrigation Pump CEDTP100, Medtronic, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/diamondtemp-irrigation-pump-cedtp100 (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/diamondtemp-irrigation-pump-cedtp100.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/diamondtemp-irrigation-pump-cedtp100
- 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.