Rowley Biochemical Jax Bouins

Basic Information

• Brand Name: Rowley Biochemical Jax Bouins
• Primary DI: SO1030852042008
• Version / Model: 1
• Catalog Number: SO-1030
• Company Name: TRANSENE COMPANY, INC.
• Labeler DUNS: 044815983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-13
• Public Version: 1
• Public Version Date: 2019-09-23
• Public Version Status: New
• Public Device Record Key: 9ff38fb7-fdee-4aed-bf8f-047895519313

Device Description

Jax Bouin's

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: Yes
• 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
IGN	Fluid, Bouin'S	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32948	Bouin's solution IVD	A solution typically prepared with saturated picric acid, formaldehyde, and glacial acetic acid intended to be used as a fixative in the processing of biological tissues and clinical specimens. Bouin?s solution is frequently used as a fixative for chromosomes undergoing mitosis or meiosis in soft or delicate tissues such as testes, or gastrointestinal (GI) tract and endocrine tissues.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	SO1030852042008	HIBCC

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Gallon
Total Volume	1	Quart
Total Volume	1	Pint
Total Volume	8	Fluid Ounce
Total Volume	4	Fluid Ounce