Inject-Ease IE400

GUDID 00025294874007

Holder for disposable syringes that hides the needle and makes self-injections easier

AMBI, INC.

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• Primary Device ID: 00025294874007
• NIH Device Record Key: 040a0e25-6411-4b14-94ed-c7f086937954
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inject-Ease
• Version Model Number: IE400
• Catalog Number: IE400
• Company DUNS: 929744212
• Company Name: AMBI, 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: false
• Lot Batch: true
• 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: 831-475-1765
• Email: info@ambimedinc.com
• Phone: 831-475-1765
• Email: info@ambimedinc.com
• Phone: 831-475-1765
• Email: info@ambimedinc.com
• Phone: 831-475-1765
• Email: info@ambimedinc.com
• Phone: 831-475-1765
• Email: info@ambimedinc.com
• Phone: 831-475-1765
• Email: info@ambimedinc.com
• Phone: 831-475-1765
• Email: info@ambimedinc.com

Device Dimensions

• Length: 5.4 Inch
• Width: 1.7 Inch
• Length: 5.4 Inch
• Width: 1.7 Inch
• Length: 5.4 Inch
• Width: 1.7 Inch
• Length: 5.4 Inch
• Width: 1.7 Inch
• Length: 5.4 Inch
• Width: 1.7 Inch
• Length: 5.4 Inch
• Width: 1.7 Inch
• Length: 5.4 Inch
• Width: 1.7 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00025294874007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872233

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-12-17