OneTouch Delica Plus Lancing Device OTDP Lancing Device US

GUDID 20812608030051

Box of 1 Lancing Device and 10 Sterile Lancets 30 Gauge

ASAHI POLYSLIDER COMPANY,LIMITED

Manual blood lancing device, reusable

• Primary Device ID: 20812608030051
• NIH Device Record Key: 60b57cde-2967-47ef-bff3-343b0d77a3ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Delica Plus Lancing Device
• Version Model Number: 02397301
• Catalog Number: OTDP Lancing Device US
• Company DUNS: 718296825
• Company Name: ASAHI POLYSLIDER COMPANY,LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true

Customer Support Contacts

• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com
• Phone: 1 888 567-3003
• Email: customerservice@lifescan.com

Device Dimensions

• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812608030057 [Primary]
GS1	20812608030051 [Package]; Contains: 00812608030057; Package: Cardboard box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221546

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-28

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• 50389701009235 - CAPIJECT SAFETY LANCET: 2023-08-09 Box of 200 Sterile Single-Use Lancing Device Needle 28G
• 84580505780659 - HemoCue Safety Lancet: 2022-12-08 Box of 200 Sterile Single-Use Lancing Device 23 Gauge
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• 00812608030149 - OneTouch Delica Plus Lancet: 2022-09-28 Box of 30 Sterile Lancets 30 Gauge