ACCU-CHEK PERFORMA 05959551001

GUDID 00365702457102

ACCU-CHEK PERFORMA PROF METER KIT US F2

Roche Diagnostics Operations, Inc.

Glucose IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00365702457102
• NIH Device Record Key: 752ebefd-e1a7-478d-8ee5-f91e67320926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCU-CHEK PERFORMA
• Version Model Number: 05959551001
• Catalog Number: 05959551001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00365702457102 [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