REMEL

Basic Information

• Brand Name: REMEL
• Primary DI: 00848838031267
• Version / Model: R40036
• Catalog Number: R40036
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-23
• Public Version: 2
• Public Version Date: 2023-08-28
• Public Version Status: Update
• Public Device Record Key: 03c935f2-bb38-4908-a988-a621674874a7
• Distribution End Date: 2023-08-03

Device Description

Schaudinn's Fixative BTL/500ml

Device Characteristics

• Single Use: No
• 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
IFQ	Formulations, Mercuric Chloride For Tissue	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57910	Faecal specimen container IVD, fixative	A covered plastic receptacle containing a fixative solution [e.g., sodium acetate, acetic acid and/or formaldehyde (SAF), Schaudinn’s, polyvinyl alcohol (PVA) or acid alcohol] intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of intestinal parasites and/or their eggs (ova)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838031267	GS1