Equashield

Basic Information

• Brand Name: Equashield
• Primary DI: 07290013484642
• Version / Model: Sampling kit syringe 60ml
• Catalog Number: SK-60/2
• Company Name: EQUASHIELD MEDICAL LTD
• Labeler DUNS: 533172743
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-20
• Public Version: 1
• Public Version Date: 2022-02-28
• Public Version Status: New
• Public Device Record Key: f4afa014-0482-409d-8506-e9ed29d3d024

Device Description

The Sampling Kit Syringe is used for general purpose laboratory use. It is intended to be used for specific medical use, such as collecting a sample from an IV bag and transferring it to laboratory tubes for further testing

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KJG	Tube, Tissue Culture	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41646	Compounding transfer set	A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290013484642	GS1
Package	17290013484649	GS1	Box	18	In Commercial Distribution
Package	27290013484646	GS1	Case	36	In Commercial Distribution