Certa Dose® Epinephrine Convenience Kit CD-EPI-001

GUDID 00860425001606

The Epinephrine Convenience Kit contains a vial of Epinephrine 1mg/mL (1:1000) and two (2) Certa Dose Epinephrine Syringe Devices that are modifications of an existing and commonly used syringe device. The Certa Dose Epinephrine Syringe Device started as an unlabeled off the shelf 3/10 mL syringe that has been modified to use mL graduation marks with color zones that align with color zones that correspond to pediatric weight ranges that can be used as a secondary confirmation that measured volumes are within ranges that are common for a patient’s weight. The Kit is intended for use in clinical and emergency medical settings to assist healthcare professionals and emergency medical personnel in measuring a desired volume of epinephrine for delivery to pediatric patients.

CERTA DOSE, INC.

General-purpose syringe/needle

• Primary Device ID: 00860425001606
• NIH Device Record Key: f352db95-2603-46d7-8b09-a20af2c971f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Certa Dose® Epinephrine Convenience Kit
• Version Model Number: 1
• Catalog Number: CD-EPI-001
• Company DUNS: 080838004
• Company Name: CERTA DOSE, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: 844-477-8607
• Email: info@certadose.com

Device Dimensions

• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge
• Needle Gauge: 29 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860425001606 [Package]; Contains: 00860425001613; Package: Case Carton [5 Units]; In Commercial Distribution
GS1	00860425001613 [Primary]
GS1	10860425001603 [Package]; Package: Shipper of 60 [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160589

FDA Product Code

• PQX: Epinephrine Syringe

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-31
• Device Publish Date: 2018-11-30