AccessGUDID - DEVICE: CONTOUR® NEXT (10301937312219)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR® NEXT
Version or Model: 7312
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 83624788
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 10301937312219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).

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):	Yes
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?
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZO	Artificial Pancreas Device System, Threshold Suspend
NBW	System, Test, Blood Glucose, Over The Counter
LFR	Glucose Dehydrogenase, Glucose
OZP	Artificial Pancreas Device System, Single Hormonal Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121190	000
K160430	000
K162336	000
K191286	000
K193407	000
K210687	000
K223293	000
K241787	000
P150001	000
P160017	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 Temperature: between 41 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store test strips in their original bottle only. Always close the lid immediately and tightly after removing a test strip. Do not use after expiration date.
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44ed198d-216c-4ada-831a-b89354b8d201
Public Version Date: April 01, 2025
Public Version Number: 9
DI Record Publish Date: August 25, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40301939737219	12	00301937312212	2021-03-18	Not in Commercial Distribution	case
00301937312212	2	10301937312219		In Commercial Distribution	carton
40301937312210	12	00301937312212		In Commercial Distribution	case
40301935541049	4	00301937312212	2022-03-23	Not in Commercial Distribution	shipper / speed pack
40301939770513	2	00301937312212		In Commercial Distribution	shipper/case