AccessGUDID - DEVICE: Accu-Chek Combo (04015630880119)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-Chek Combo
Version or Model: 05027250001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Roche Diabetes Care GmbH

Primary DI Number: 04015630880119
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 313212471 *Terms of Use

Device Description: Accu-Chek Spirit Combo

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):	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?
51083	Ambulatory insulin infusion pump/blood glucose analyser system	An assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZG	Pump, Infusion, Insulin

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: 4a328b24-223c-411b-93cd-9047ff15b125
Public Version Date: July 25, 2023
Public Version Number: 3
DI Record Publish Date: August 25, 2016