J-Tip

Basic Information

• Brand Name: J-Tip
• Primary DI: B07281641001
• Version / Model: 8164200125
• Catalog Number: 8164-2001-25
• Company Name: NATIONAL MEDICAL PRODUCTS, INC.
• Labeler DUNS: 019473664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-27
• Public Version: 1
• Public Version Date: 2024-06-04
• Public Version Status: New
• Public Device Record Key: 0ac4519b-d9fc-49d1-9bcc-2d4a6399ec66

Device Description

J-Tip Needleless Injector System is used for the subcutaneous administrations of xylocaine or calcimar/calcitonin which are appropriate for the injection using jet injection or needleless injection systems. For subcutaneous injection only. The device serves as an alternative to the subcutaneous delivery of xylocaine or calcimar/calcitionin medications with needle and syringe.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
KZE	Injector, Fluid, Non-Electrically Powered	General Hospital	880.5430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18069	Needleless medication/vaccine injector, mechanical	A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (especially a local anaesthetic, vaccine or medication) transcutaneously into the human body. It is a manually-operated, needleless device that can have various configurations according to application. It will typically be a pistol-shaped plunger driven instrument with single or multi-pointed holed barrels through which the medication/vaccine is driven under high pressure. The delivered medication/vaccine will typically be supplied in prefilled containers. This device is not a hypodermic syringe. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B07281642001	HIBCC	sherf box	25	In Commercial Distribution
Primary	B07281641001	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	0.25	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius