AccessGUDID - DEVICE: Medichoice (10885632106057)

GUDID

Device Identifier (DI) Information

Brand Name: Medichoice
Version or Model: 916820A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632106057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Thermometer Digital Oral Rectal Dual-Scale Neutral Cap 35-90 Second Read Time Not Made With Natural Rubber Latex MediChoice

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?
37340	General-purpose patient temperature probe, reusable	A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify:
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 800 and 1060 KiloPascal
Special Storage Condition, Specify: Do not Store in direct sunlight or extreme heat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d10fdb2e-19fe-4fc8-a33f-2e65d4e7e3d3
Public Version Date: June 22, 2018
Public Version Number: 3
DI Record Publish Date: August 20, 2016