OneTouch Delica Plus Lancet OTDP Lancet 30g 30 US

GUDID 00812608030149

Box of 30 Sterile Lancets 30 Gauge

ASAHI POLYSLIDER COMPANY,LIMITED

Blood lancing device tip
Primary Device ID00812608030149
NIH Device Record Key412cd8ed-4bbd-4284-b0ea-6ec234dacaf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch Delica Plus Lancet
Version Model Number02419901
Catalog NumberOTDP Lancet 30g 30 US
Company DUNS718296825
Company NameASAHI POLYSLIDER COMPANY,LIMITED
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com
Phone1 888 567-3003
Emailcustomerservice@lifescan.com

Device Dimensions

Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100812608030149 [Unit of Use]
GS100812608030217 [Primary]
GS120812608030211 [Package]
Contains: 00812608030217
Package: Cardboard box [240 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-09-28
Device Publish Date2020-11-18

On-Brand Devices [OneTouch Delica Plus Lancet]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.