JJ CARE

Basic Information

• Brand Name: JJ CARE
• Primary DI: 05060988910161
• Version / Model: JJ033108-100
• Company Name: Jack Jack LLC
• Labeler DUNS: 052514128
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-15
• Public Version: 2
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: c3987448-8d87-48e6-b1c5-cfc94d1f9b3c

Device Description

Insulin syringes are used for administering the prescribed insulin dose to diabetic patients. The subcutaneous administration of insulin is meant to imitate the naturally occurring pancreatic secretions. The insulin injection is typically put on the abdomen, arms, thighs, and buttocks. JJ CARE Insulin Syringes are disposable and meant for one time use. Insulin Syringe U-100, 0.3cc/ml 31G 5/16" (Pack of 100)

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38501	Insulin syringe/needle, basic	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060988910161	GS1
Package	25060988910165	GS1	Case	150	In Commercial Distribution
Direct Marking	15060988910168	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			U-100, 0.3cc/ml 31G 5/16"

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The products should be stored in a dry, well-ventilated room, keep away from any corrosive gas.