AccessGUDID - DEVICE: KAI Lifestyle&Wellness (06953825905576)

GUDID

Device Identifier (DI) Information

Brand Name: KAI Lifestyle&Wellness
Version or Model: UFR102
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Urion Technology Co., Ltd

Primary DI Number: 06953825905576
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 421294358 *Terms of Use

Device Description: No description.

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?
58391	Medical device pressure monitor	A mechanical device designed to be connected to another device or system of devices (e.g., rectal suction biopsy system) to provide an accurate indication of the amount of negative pressure being applied in these devices during a surgical intervention or other procedure. It typically consists of a simple column that has incremented markings on its side(s) [e.g., in - cmH2O or - mmH2O], an indicator that shows the amount of negative pressure, and connectors for tubing that connect it to the operative device(s). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200802	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: 77e24c39-c084-46f8-8ba6-5660bd2df796
Public Version Date: April 22, 2022
Public Version Number: 2
DI Record Publish Date: January 23, 2022