Certa Dose PALS Syringe Holder

Primary DI
00860425001620
Brand
Certa Dose PALS Syringe Holder
Company
CD Acquisitions, LLC
Model
CD-PALS-0001
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
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQGAdaptor, Holder, Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQGAdaptor, Holder, SyringePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860425001651PackageGS14In Commercial Distribution
10860425001658PackageGS112In Commercial Distribution
00860425001620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860425001651008604250016518604250016510860425001651
1086042500165810860425001658
00860425001620008604250016208604250016200860425001620

GMDN Terms#

Term, Definition table
TermDefinition
Syringe/ampule clipA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-477-8607info@certadose.com

Regulatory Flags#

DUNS number
118817131
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012210800Certa Dose1CD-EPI-001-NV2024-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974405095180CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097290CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097306CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097313CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097320CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
06974405097559CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IQG2026-05-26
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