OneTouch Delica Plus Lancet OTDP Lancet 30g 100 US

GUDID 20812608030020

Box of 100 Sterile Lancets 30 Gauge

ASAHI POLYSLIDER COMPANY,LIMITED

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip

• Primary Device ID: 20812608030020
• NIH Device Record Key: 35a5d71e-fa30-4873-bf0f-3eff7f79abcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Delica Plus Lancet
• Version Model Number: 02401101
• Catalog Number: OTDP Lancet 30g 100 US
• Company DUNS: 718296825
• Company Name: ASAHI POLYSLIDER COMPANY,LIMITED
• 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: 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	00812608030026 [Primary]
GS1	00812608030149 [Unit of Use]
GS1	20812608030020 [Package]; Contains: 00812608030026; Package: Cardboard box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221546

FDA Product Code

• FMK: Lancet, Blood
• 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: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [OneTouch Delica Plus Lancet]

• 20812608030020: Box of 100 Sterile Lancets 30 Gauge
• 00812608030019: Box of 100 Sterile Lancets 33 Gauge
• 00812608030156: Bag of 10 sterile lancets 30 Gauge
• 20812608030037: Bag of 10 sterile lancets 33 Gauge
• 00812608030149: Box of 30 Sterile Lancets 30 Gauge