Certa Dose® Epinephrine Convenience Kit

Primary DI
00860425001606
Brand
Certa Dose® Epinephrine Convenience Kit
Company
CERTA DOSE, INC.
Model
1
Catalog number
CD-EPI-001
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.
Published
2018-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQXEpinephrine Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQXEpinephrine SyringeGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160589000Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.2017-01-19PQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860425001606PackageGS15In Commercial Distribution
10860425001603PackageGS112In Commercial Distribution
00860425001613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860425001606008604250016068604250016060860425001606
1086042500160310860425001603
00860425001613008604250016138604250016130860425001613

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge29Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-477-8607info@certadose.com

Regulatory Flags#

DUNS number
080838004
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860425001613Certa Dose® Epinephrine Convenience Kit1CD-EPI-0012018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012210800Certa DoseCD Acquisitions, LLCPQX2024-10-17
00860425001613Certa Dose® Epinephrine Convenience KitCERTA DOSE, INC.PQX2018-11-30