AccessGUDID - DEVICE: Accu-Chek Compact Plus (00365702701236)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Chek Compact Plus
Version or Model: 06444393001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Roche Diagnostics Operations, Inc.

Primary DI Number: 00365702701236
Issuing Agency: GS1
Commercial Distribution End Date: October 25, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 141608724 *Terms of Use

Device Description: Accu-Chek Compact Plus Control L2 (Bio) The UDI information was not placed on the vial label due to the new kit guidance that was published.

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?
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
LFR	Glucose Dehydrogenase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 1ab23cb1-b4ee-41cf-8d9a-9b16d7c7da3c
Public Version Date: April 29, 2019
Public Version Number: 3
DI Record Publish Date: August 26, 2016