AccessGUDID - DEVICE: J-Tip (B07281641001)

GUDID

Device Identifier (DI) Information

Brand Name: J-Tip
Version or Model: 8164200125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8164-2001-25
Company Name: NATIONAL MEDICAL PRODUCTS, INC.

Primary DI Number: B07281641001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 019473664 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZE	Injector, Fluid, Non-Electrically Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.25 Milliliter

Device Record Status

Public Device Record Key: 0ac4519b-d9fc-49d1-9bcc-2d4a6399ec66
Public Version Date: June 04, 2024
Public Version Number: 1
DI Record Publish Date: May 27, 2024