AccessGUDID - DEVICE: Disposable Thermometer Cover and Sheaths (06972543480127)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Thermometer Cover and Sheaths
Version or Model: 9225
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KANG ZE INDUSTRIAL CO., LTD

Primary DI Number: 06972543480127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30000
Labeler D-U-N-S® Number*: 542345014 *Terms of Use

Device Description: The Disposable Thermometer Covers and Sheaths are intended for use as barriers between digital or mercury thermometers and users’ rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These covers and sheaths are non-sterile and intended for single use only.

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":	Yes
For Single-Use:	Yes
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?
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLK	Thermometer, Clinical Mercury
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112289	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: 104b209c-a794-4f3d-bac2-a77a26191b97
Public Version Date: September 02, 2019
Public Version Number: 1
DI Record Publish Date: August 23, 2019