Genetic Testing - Saliva IG

Basic Information

• Brand Name: Genetic Testing - Saliva IG
• Primary DI: 00860013131265
• Version / Model: 136350
• Company Name: Medzah Industries
• Labeler DUNS: 114193536
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-27
• Public Version: 2
• Public Version Date: 2024-12-11
• Public Version Status: Update
• Public Device Record Key: a77d33a0-6a36-44be-96b8-1812aab2625c

Device Description

Genetic Testing - Saliva IG

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43651	General specimen receptacle transport container	A non-powered portable device designed for the transportation of clinical specimens contained within 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 designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013131265	GS1