AccessGUDID - DEVICE: ACCU-CHEK GUIDE (00365702712102)

GUDID

Device Identifier (DI) Information

Brand Name: ACCU-CHEK GUIDE
Version or Model: 07453744001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07453744001
Company Name: Roche Diagnostics Operations, Inc.

Primary DI Number: 00365702712102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 141608724 *Terms of Use

Device Description: ACCU-CHEK GUIDE 100CT STRIP 24/CS

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):	No
Over the Counter (OTC):	No
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?
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFR	Glucose Dehydrogenase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160944	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: f16dafa4-1ef5-450e-a5a7-589db593b614
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 04, 2017