AccessGUDID - DEVICE: Physiologic Accuflex 10 Flexible Digital Thermometer (00057565166351)

GUDID

Device Identifier (DI) Information

Brand Name: Physiologic Accuflex 10 Flexible Digital Thermometer
Version or Model: 016-635 Version 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 016-635
Company Name: A.M.G. Médicale Inc

Primary DI Number: 00057565166351
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207372814 *Terms of Use
Previous DI: 05756516635100

Device Description: The Accuflex 10 flexible digital thermometer provides clinically proven accuracy in just under 10 seconds. • For use orally, rectally or underarm Accurate within 0.2°F/0.1°C Beep signals peak temperature Waterproof probe/ washable for easy cleaning

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14035	Intermittent electronic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75fdd63d-7dcb-4100-b997-acbbbe194f1b
Public Version Date: August 21, 2020
Public Version Number: 4
DI Record Publish Date: October 26, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05756595756000	6	00057565166351	In Commercial Distribution
05756598238862	12	05756595756000	In Commercial Distribution
10057565166358	6	00057565166351	In Commercial Distribution	Inner case
20057565166355	12	10057565166358	In Commercial Distribution	Master case