AccessGUDID - DEVICE: CONTOUR® (10301937080507)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR®
Version or Model: 7080G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6707113
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 10301937080507
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. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - RDC # 0193-7090-21).

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
LFR	Glucose Dehydrogenase, Glucose
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062058	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 48 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 806f9ad7-8f79-4fef-8a6a-1023a14a3476
Public Version Date: November 06, 2024
Public Version Number: 5
DI Record Publish Date: September 16, 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
40301939727210	12	00301937090219	2017-07-31	Not in Commercial Distribution	shipper/case
00301937090219	2	10301937080507		In Commercial Distribution	carton
40301939726503	24	00301937080500	2017-07-31	Not in Commercial Distribution	shipper/case
00301937080500	1	10301937080507		In Commercial Distribution	carton
40301937090217	12	00301937090219		In Commercial Distribution	shipper/case
40301937080508	24	00301937080500		In Commercial Distribution	shipper/case
40301939603040	4	00301937090219		In Commercial Distribution	shipper / speed pack
40301939602043	4	00301937080500		In Commercial Distribution	shipper / speed pack