NeedleSafe

GUDID 00725030550102

NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include: At every bedside On medication carts Injection trays Phlebotomy trays Critical Care Units Endoscopy Suites Pharmacy Anesthesia/Surgery Pathology Emergency Department Psychiatric wards NeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol.

INGENIOUS TECHNOLOGIES CORPORATION

Needle recapping device, reusable

• Primary Device ID: 00725030550102
• NIH Device Record Key: 840556f4-5de5-4c03-b107-c9fdfd7f37b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeedleSafe
• Version Model Number: II
• Company DUNS: 847274867
• Company Name: INGENIOUS TECHNOLOGIES CORPORATION
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 941-586-6690
• Email: slin@ingenious.com
• Phone: 941-586-6690
• Email: slin@ingenious.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00725030550102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K936235

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23