J-Tip 8164-2001-25

GUDID B07281642001

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.

NATIONAL MEDICAL PRODUCTS, INC.

Needleless medication/vaccine injector, mechanical

• Primary Device ID: B07281642001
• NIH Device Record Key: 0ac4519b-d9fc-49d1-9bcc-2d4a6399ec66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J-Tip
• Version Model Number: 8164200125
• Catalog Number: 8164-2001-25
• Company DUNS: 019473664
• Company Name: NATIONAL MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com
• Phone: 9492853517
• Email: cblake@jtip.com

Device Dimensions

• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter
• Total Volume: 0.25 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07281641001 [Primary]
HIBCC	B07281642001 [Package]; Contains: B07281641001; Package: sherf box [25 Units]; In Commercial Distribution

FDA Product Code

• KZE: Injector, Fluid, Non-Electrically Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-04
• Device Publish Date: 2024-05-27