OneTouch Delica Plus Lancet OTDP Lancet 33g 100 US

GUDID 00812608030019

Box of 100 Sterile Lancets 33 Gauge

ASAHI POLYSLIDER COMPANY,LIMITED

Blood lancing device tip

• Primary Device ID: 00812608030019
• NIH Device Record Key: fbd55a48-7c88-411c-b032-cba6795b2434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Delica Plus Lancet
• Version Model Number: 02400801
• Catalog Number: OTDP Lancet 33g 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: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge
• Needle Gauge: 33 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812608030019 [Primary]
GS1	00812608030149 [Unit of Use]
GS1	20812608030013 [Package]; 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