OneTouch Delica Plus Lancing Device

Basic Information

• Brand Name: OneTouch Delica Plus Lancing Device
• Primary DI: 00812608030057
• Version / Model: 02397301
• Catalog Number: OTDP Lancing Device US
• Company Name: ASAHI POLYSLIDER COMPANY,LIMITED
• Labeler DUNS: 718296825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-28
• Public Version: 2
• Public Version Date: 2022-09-28
• Public Version Status: Update
• Public Device Record Key: 60b57cde-2967-47ef-bff3-343b0d77a3ae

Device Description

Box of 1 Lancing Device and 10 Sterile Lancets 30 Gauge

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	878.4850	2
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
37243	Manual blood lancing device, reusable	A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a reusable device.	No	Active
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	20812608030051	GS1	Cardboard box	24	In Commercial Distribution
Primary	00812608030057	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221546	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	30	Gauge