Identity
- Trade Name
- Certa Dose FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- CD-EPI-001-NV FDA UDI
- Primary DI / UDI-DI
- 00860012210800 FDA UDI
- 510(k) Number
- K160589 FDA UDI
- FDA Product Code
- PQX FDA UDI
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.3 Milliliter FDA UDILength — 0.5 Inch FDA UDINeedle Gauge — 29 Gauge FDA UDI
Category: General-purpose syringe/needle
Certa Dose by CD Acquisitions, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160589 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CD Acquisitions, LLC
Sources (1)
- FDA UDI 451c4ff8-208b-4021-b2a5-0b32420d04f8 38 fields · synced Jun 8, 2026