AccessGUDID - DEVICE: American Red Cross (84617503103019)

GUDID

Device Identifier (DI) Information

Brand Name: American Red Cross
Version or Model: DET-103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR3103
Company Name: CREATIVE CONCEPTS MANUFACTURING LIMITED

Primary DI Number: 84617503103019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 680004711 *Terms of Use

Device Description: Intended Use This thermometer is intended to measure core body temperature of infants and adults through the ear. It can also measure surface temperatures of objects like baby bottles. Advantages of Using an Ear Thermometer The eardrum shares blood supply with the hypothalamus which makes for a more accurate reading than other body parts.

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):	Yes
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?
17887	Infrared patient thermometer, ear	A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. 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: cc336fae-2104-4eed-95df-c7bd4b131bfe
Public Version Date: November 29, 2021
Public Version Number: 1
DI Record Publish Date: November 19, 2021