AccessGUDID - DEVICE: Certa Dose® Epinephrine Convenience Kit (00860425001613)

GUDID

Device Identifier (DI) Information

Brand Name: Certa Dose® Epinephrine Convenience Kit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD-EPI-001
Company Name: CERTA DOSE, INC.

Primary DI Number: 00860425001613
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080838004 *Terms of Use

Device Description: 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.

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63095	General-purpose syringe/needle	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQX	Epinephrine Syringe

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160589	000

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
Handling Environment Temperature: between 20 and 25 Degrees Celsius
Special Storage Condition, Specify: Protect from light/sunlight
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: .3 Milliliter
Length: .5 Inch
Needle Gauge: 29 Gauge

Device Record Status

Public Device Record Key: f352db95-2603-46d7-8b09-a20af2c971f4
Public Version Date: January 31, 2019
Public Version Number: 3
DI Record Publish Date: November 30, 2018