Certa Dose PALS Syringe Holder

Basic Information

• Brand Name: Certa Dose PALS Syringe Holder
• Primary DI: 00860425001620
• Version / Model: CD-PALS-0001
• Company Name: CD Acquisitions, LLC
• Labeler DUNS: 118817131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-03
• Public Version: 1
• Public Version Date: 2025-03-11
• Public Version Status: New
• Public Device Record Key: 005e6081-f2f4-424f-a368-4deda4480ce1

Device Description

A small device intended to be used to clip to the syringe used to withdraw the medication it contained, during the administration of medication to a patient, in order to identify the type of medication in the syringe to help prevent the misadministration of the medication. It is made of plastic material and designed to be clipped to the base of either a Luer or a Luer-lock syringe. It is typically used by ambulance paramedics, personnel in accident and emergency (A&E) rooms. This is a single-use device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQG	Adaptor, Holder, Syringe	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46240	Syringe/ampule clip	A small device intended to be used to clip an empty ampule to the syringe used to withdraw the medication it contained, during the administration of medication to a patient, in order to identify the type of medication in the syringe to help prevent the misadministration of the medication. It is typically made of plastic material (e.g., polypropylene) and designed to be clipped to the base of either a Luer or a Luer-lock syringe tip by means of a clamp, and to hold the ampule by means of expandable barbs. It is typically used by ambulance paramedics, personnel in accident and emergency (A&E) rooms, and anaesthetists. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860425001620	GS1
Package	00860425001651	GS1	Case Carton	4	In Commercial Distribution
Package	10860425001658	GS1	Shipper of 48	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]