Accu-Chek Compact Plus 05919967160

GUDID 00075537598849

ACCU-CHEK COMPACT PLUS 102CT RTL STR 24

Roche Diabetes Care GmbH

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

• Primary Device ID: 00075537598849
• NIH Device Record Key: 447db7cd-477f-45c2-b7a9-78f482c7824e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Compact Plus
• Version Model Number: 05919967160
• Catalog Number: 05919967160
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• Device Count: 6
• 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: true
• Serial Number: false
• 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	00075537598849 [Primary]
GS1	10075537598846 [Package]; Package: [24 Units]; In Commercial Distribution
GS1	50075537598844 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113614

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-26

On-Brand Devices [Accu-Chek Compact Plus]

• 00365702468108: Accu-Chek Compact Plus Clear Control USA
• 00075537927144: ACCU-CHEK COMPACT PLUS 51 CT MO STRP 48
• 00075537598849: ACCU-CHEK COMPACT PLUS 102CT RTL STR 24
• 00075537546611: Accu-Chek Compact Plus MIC 1x17 Str
• 00075537474198: ACCU-CHEK COMPACT PLUS 51 CT RTL STR 48