FDA.reportPublic FDA data

Certa Dose

Primary DI
00860012210800
Brand
Certa Dose
Company
CD Acquisitions, LLC
Model
1
Catalog number
CD-EPI-001-NV
Device description
The Epinephrine Convenience Kit contains two (2) Certa Dose Epinephrine Syringe Devices that are modifications of an existing and commonly used syringe device. The Certa Dose Epinephrine Syringe Device is a 3/10 mL syringe that has 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
2024-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00860012210817PackageGS15In Commercial Distribution
10860012210814PackageGS112In Commercial Distribution
00860012210800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012210817008600122108178600122108170860012210817
1086001221081410860012210814
00860012210800008600122108008600122108000860012210800

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch
Needle Gauge29Gauge
Total Volume0.3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Protect from Light/Sunlight
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
118817131
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860425001620Certa Dose PALS Syringe Holder CD-PALS-00012025-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860425001613Certa Dose® Epinephrine Convenience KitCERTA DOSE, INC.PQX2018-11-30
00860425001606Certa Dose® Epinephrine Convenience KitCERTA DOSE, INC.PQX2018-11-30