MICROLET® 81264857, 81264954 (US)

GUDID 40301936586124

Colored lancets. Silicone-coated lancets. Use with the MICROLET Family of lancing devices.

ASCENSIA DIABETES CARE US INC.

Blood lancing device tip

• Primary Device ID: 40301936586124
• NIH Device Record Key: 55dfab27-fce9-4952-97fc-e7516661e22c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROLET®
• Version Model Number: 6586 / 6586W
• Catalog Number: 81264857, 81264954 (US)
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Customer Support Contacts

• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if protective cap has been previously removed. Do not reuse.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301936586010 [Unit of Use]
GS1	00301936586218 [Primary]
NDC/NHRIC	0193-6586-21 [Secondary]
GS1	40301936586124 [Package]; Contains: 00301936586218; Package: shipper/case [12 Units]; In Commercial Distribution
GS1	40301936586216 [Package]; Contains: 00301936586218; Package: shipper/case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220633

FDA Product Code

• FMK: Lancet, Blood
• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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: 2019-06-14
• Device Publish Date: 2019-06-06

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