AccessGUDID - DEVICE: Amazrock (08883000001749)

GUDID

Device Identifier (DI) Information

Brand Name: Amazrock
Version or Model: Amaz-HC1001401
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AMAZROCK PTE. LTD.

Primary DI Number: 08883000001749
Issuing Agency: GS1
Commercial Distribution End Date: April 06, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 659258748 *Terms of Use

Device Description: AMAZROCK Digital Infrared Thermometer Dual Mode supports temperature scan via Forehead or Eardrum Detection. It is designed for use with adults and children. Modern Design & Convenient to Use - Ergonometric design to facilitate easy use across all ages. - The back-light screen makes it very convenient to use at night or under dim lighting conditions. - Rapid and accurate reading with 1 second measurement time. - Forehead scan mode makes it convenient to measure temperature while your child is sleeping. - Eardrum temperature detection mode is only suitable for use for ages 3 months & above. - Easy & Comfortable use experience as compared with other thermometer(s). Simple operations with just 2 buttons - “Head” (Forehead temperature detection) or “Ear” (Eardrum temperature scan). - Supports 20 readings memory recall. - Comes with two AAA batteries for immediate use.

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?
17888	Infrared patient thermometer, skin	A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. 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 [?]
K131243	000

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: c7161f12-33e3-4a1c-8c88-d9156a8168f8
Public Version Date: December 04, 2020
Public Version Number: 5
DI Record Publish Date: June 30, 2017