OneTouch Delica Plus Lancet

Basic Information

• Brand Name: OneTouch Delica Plus Lancet
• Primary DI: 00812608030033
• Version / Model: 013-026
• Catalog Number: OTDP Lancet Bag 33g US/CA
• Company Name: ASAHI POLYSLIDER COMPANY,LIMITED
• Labeler DUNS: 718296825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-01-31
• Public Version: 2
• Public Version Date: 2022-09-28
• Public Version Status: Update
• Public Device Record Key: e02413b6-d700-426e-b27a-c90a6cb50e80

Device Description

Bag of 10 sterile lancets 33 Gauge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20812608030037	GS1	Cardboard box	1000	In Commercial Distribution
Primary	00812608030033	GS1
Unit of Use	00812608030149	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221546	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	33	Gauge