Accu-Chek Softclix 03144844001

GUDID 04015630084937

Accu-Chek Softclix Lancets 10/pk

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable

• Primary Device ID: 04015630084937
• NIH Device Record Key: 0b407ee6-dac9-40ca-a9da-1a8deeb02be3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Softclix
• Version Model Number: 03144844001
• Catalog Number: 03144844001
• 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: true
• 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	04015630084937 [Primary]

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-05
• Device Publish Date: 2022-09-27

On-Brand Devices [Accu-Chek Softclix]

• 04015630084937: Accu-Chek Softclix Lancets 10/pk
• 04015630082209: Accu-Chek Softclix Black Bulk 100
• 00365702897106: Accu-Chek Softclix Mailorder 100ct 12/cs
• 00365702700123: Accu-Chek Softclix AST Kit USA
• 00365702400108: Accu-Chek Softclix (black) USA 12/case
• 00365702156104: Accu-Chek Softclix HN Lancets 100ct 12cs
• 00075537009710: Accu-Chek Softclix Lancets 100ct 12/cs
• 10365702702827: Accu-Chek Softclix Kit Canada