JJ CARE

Basic Information

• Brand Name: JJ CARE
• Primary DI: 15060988910007
• Version / Model: HH-X-T, IC
• Company Name: Jack Jack LLC
• Labeler DUNS: 052514128
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4951
• Record Status: Published
• Publish Date: 2023-03-15
• Public Version: 1
• Public Version Date: 2023-03-23
• Public Version Status: New
• Public Device Record Key: 7d91aa4d-70b7-45d7-9c93-bd06f6aa3fc3

Device Description

Lancing Device with Twist Off Lancets

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	878.4850	2
QRL	Multiple Use Blood Lancet For Single Patient Use Only	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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060988910007	GS1
Package	25060988910004	GS1	Case	150	In Commercial Distribution
Unit of Use	05060988910000	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			No Device Sizes