AccessGUDID - DEVICE: WowGoHealth Blood Glucose Test Strips - GSH-BGM902

GUDID

Device Identifier (DI) Information

Brand Name: WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25
Version or Model: GSH-BGM902 - 2*25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GOLDEN SMART HOME TECHNOLOGY CORP.

Primary DI Number: 04719878121125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 656002163 *Terms of Use

Device Description: The WowGoHealth Blood Glucose Test Strip is for the measurement of glucose in whole blood. It is for In-vitro diagnostic use only. And the WowGoHealth test strips can only be used with WowGoHealth meter that has the same reference number.

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:	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?
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFR	Glucose Dehydrogenase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141351	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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 560cdc4a-2839-48e3-b312-42526b78f2db
Public Version Date: July 12, 2019
Public Version Number: 1
DI Record Publish Date: July 04, 2019