Accu-Chek Compact Plus 05599415160

GUDID 00075537474198

ACCU-CHEK COMPACT PLUS 51 CT RTL STR 48

Roche Diabetes Care GmbH

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: 00075537474198
• NIH Device Record Key: 15f41180-f8fb-44f8-86c6-b17b65b3938b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Compact Plus
• Version Model Number: 05599415160
• Catalog Number: 05599415160
• Company DUNS: 313212471
• Company Name: Roche Diabetes Care GmbH
• Device Count: 3
• 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	00075537474198 [Primary]
GS1	10075537474195 [Package]; Package: [48 Units]; In Commercial Distribution
GS1	50075537474193 [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: 2016-08-25

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