Histoplex

Basic Information

• Brand Name: Histoplex
• Primary DI: 10840165401062
• Version / Model: H602-FL
• Company Name: Pretium Canada Packaging ULC
• Labeler DUNS: 246665038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-03-04
• Public Version: 1
• Public Version Date: 2025-03-12
• Public Version Status: New
• Public Device Record Key: 5e02c3e0-fa2b-4742-99a0-d62479ec52ec

Device Description

Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile.

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: 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
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63838	General tissue specimen container IVD, no additive	A covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840165401072	GS1		5	In Commercial Distribution
Primary	10840165401062	GS1
Unit of Use	00840165401065	GS1