# Temperature Probe 06320480210

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

- Canonical page: <https://devicerts.com/devices/temperature-probe-06320480210>
- Manufacturer: [Instrumentation Laboratory Company](https://devicerts.com/manufacturers/instrumentation-laboratory-company) (United States)
- Name in the registry: TEMPERATURE PROBE 06320480210
- Device class: Class I (US FDA)
- FDA product code: JKS
- GMDN: Coagulation analyser IVD, laboratory, semi-automated (56690)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 08426950452614 · listed 2016-09-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K951485 · decision 1995-11-06 · decision SESE · status: Active · from GUDID

## Recalls

- Z-2218-2011 ·  · terminated · initiated 2011-03-23 · matched through shared submission K951485, may concern other models: An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
- Z-1239-2008 ·  · terminated · initiated 2008-02-13: Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.

## Identity

- Trade name: TEMPERATURE PROBE [FDA GUDID (AccessGUDID)]
- Generic name: Coagulation analyser IVD, laboratory, semi-automated [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 06320480210 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08426950452614 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K951485 [FDA GUDID (AccessGUDID)]
- FDA product code: JKS [FDA GUDID (AccessGUDID)]
- GMDN term: Coagulation analyser IVD, laboratory, semi-automated (56690) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 862.3220 [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: Temperature Probe 06320480210, Instrumentation Laboratory Company. deviCERTS medical device catalogue. https://devicerts.com/devices/temperature-probe-06320480210 (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/temperature-probe-06320480210.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/temperature-probe-06320480210
- 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.