AccessGUDID - DEVICE: Accutrend Glucose Test Strips (00365702456105)

GUDID

Device Identifier (DI) Information

Brand Name: Accutrend Glucose Test Strips
Version or Model: 11447475160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11447475160
Company Name: Roche Diagnostics GmbH

Primary DI Number: 00365702456105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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?
53304	Glucose IVD, kit, colorimetric dipstick, rapid	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	GLUCOSE OXIDASE, GLUCOSE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051376	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c102dc99-3739-4817-8d80-8d9d1b3f0e68
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016