Certa Dose CD-EPI-001-NV
GUDID 00860012210800
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.
CD Acquisitions, LLC
General-purpose syringe/needle| Primary Device ID | 00860012210800 |
| NIH Device Record Key | 451c4ff8-208b-4021-b2a5-0b32420d04f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Certa Dose |
| Version Model Number | 1 |
| Catalog Number | CD-EPI-001-NV |
| Company DUNS | 118817131 |
| Company Name | CD Acquisitions, LLC |
| 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 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com | |
| Phone | 844-477-8607 |
| info@certadose.com |
Device Dimensions
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 0.5 Inch |
| Needle Gauge | 29 Gauge |
Operating and Storage Conditions
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from Light/Sunlight |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860012210800 [Primary] |
| GS1 | 00860012210817 [Package] Package: Case Carton [5 Units] In Commercial Distribution |
| GS1 | 10860012210814 [Package] Contains: 00860012210817 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-25 |
| Device Publish Date | 2024-10-17 |
Trademark Results [Certa Dose]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERTA DOSE 86008904 not registered Dead/Abandoned |
Certa Dose, Inc. 2013-07-12 |
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