AccessGUDID - DEVICE: Certa Dose PALS Syringe Holder (00860425001620)

GUDID

Device Identifier (DI) Information

Brand Name: Certa Dose PALS Syringe Holder
Version or Model: CD-PALS-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CD Acquisitions, LLC

Primary DI Number: 00860425001620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118817131 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQG	Adaptor, Holder, Syringe

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 005e6081-f2f4-424f-a368-4deda4480ce1
Public Version Date: March 11, 2025
Public Version Number: 1
DI Record Publish Date: March 03, 2025