AccessGUDID - DEVICE: GenUltimate (00850015460036)

GUDID

Device Identifier (DI) Information

Brand Name: GenUltimate
Version or Model: 300-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHARMA TECH SOLUTIONS, INC.

Primary DI Number: 00850015460036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 829145387 *Terms of Use

Device Description: Value Priced Test Strips for use with OneTouch®Ultra®, OneTouch® Ultra®2 and OneTouch® UltraMini® meters

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
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103542	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: bbdf07e1-f766-4df0-8b0a-ffb0267848e6
Public Version Date: January 20, 2020
Public Version Number: 1
DI Record Publish Date: January 10, 2020