AccessGUDID - DEVICE: CONTOUR® (10301937109017)

GUDID

Device Identifier (DI) Information

Brand Name: CONTOUR®
Version or Model: 7109B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6707431
Company Name: ASCENSIA DIABETES CARE US INC.

Primary DI Number: 10301937109017
Issuing Agency: GS1
Commercial Distribution End Date: January 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080028910 *Terms of Use

Device Description: Control Solution - Normal, 1 x 2.5 mL

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):	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?
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062058	000
K090628	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
Special Storage Condition, Specify: Keep out of direct sunlight. Do not use after expiration date.
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d135aa0-eb49-4352-91ae-8c063b5901b2
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 Status	Package Type
00301937109010	1	10301937109017	Not in Commercial Distribution	carton
40301937109018	12	00301937109010	Not in Commercial Distribution	in.shipper/sm.case
50301937109015	32	40301937109018	Not in Commercial Distribution	out.shipper/lg.case