Total-Fix / C&S / Clean O&P Collection Kits

Basic Information

• Brand Name: Total-Fix / C&S / Clean O&P Collection Kits
• Primary DI: M44589117ORNGE1
• Version / Model: 891-17_ORNGE
• Catalog Number: 891-17_ORNGE
• Company Name: MEDICAL CHEMICAL CORPORATION
• Labeler DUNS: 008496861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: 8c33eff4-6bb5-4780-87a3-5302b228a354

Device Description

Convenience kit containing Total Fix, C&S and Clean Vials with orange caps.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
JSM	Culture Media, Non-Propagating Transport	Microbiology	866.2390	1
LDX	Fixative, Metallic Containing	Pathology	864.4010	1
NNI	Container, Specimen, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58564	Carey-Blair transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of gram negative and anaerobic microorganisms from a clinical specimen.	No	Obsolete
33832	Fixative, metallic	An agent containing metal employed in the preparation of a histologic or pathologic human specimen for the purpose of maintaining the existing form and structure of all of its constituent elements to be used for general diagnostic applications.	No	Active
43651	General specimen receptacle transport container	A non-sterile, portable device designed for the transportation of one or multiple clinical specimen receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of sizes, shapes, and materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M44589117ORNGE0	HIBCC
Primary	M44589117ORNGE1	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius