Accu-Chek Softclix 05181186001

GUDID 04015630082209

Accu-Chek Softclix Black Bulk 100

Roche Diagnostics Operations, Inc.

Manual blood lancing device, reusable

• Primary Device ID: 04015630082209
• NIH Device Record Key: 179e002c-0532-454a-80f6-f06aed3a8676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Chek Softclix
• Version Model Number: 05181186001
• Catalog Number: 05181186001
• 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: true
• Serial Number: false
• 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	04015630082209 [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: false

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

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