ACCU-CHEK PERFORMA 04680421003

GUDID 00365702668102

ACCU-CHEK PERFORMA METER MG/DL (550)

Roche Diagnostics Operations, Inc.

Home-use/point-of-care glucose analyser IVD, battery-powered Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use Glucose analyser IVD, home-use

• Primary Device ID: 00365702668102
• NIH Device Record Key: aba02739-905a-4574-b407-7ed8ef6fff16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCU-CHEK PERFORMA
• Version Model Number: 04680421003
• Catalog Number: 04680421003
• Company DUNS: 141608724
• Company Name: Roche Diagnostics Operations, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702668102 [Primary]

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-26

On-Brand Devices [ACCU-CHEK PERFORMA]

• 00365702668102: ACCU-CHEK PERFORMA METER MG/DL (550)
• 10365702602103: ACCU-CHEK PERFORMA US 50 CT 36/CS F2
• 00365702457102: ACCU-CHEK PERFORMA PROF METER KIT US F2