Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094992020
• Version / Model: 19920/20
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-07
• Public Version: 1
• Public Version Date: 2023-12-15
• Public Version Status: New
• Public Device Record Key: 33823a97-e842-4a81-b3ad-34d23bdd6830

Device Description

Graduated Triangle Pitcher

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65807	Body fluid jug, single-use	A tall cylindrical vessel with a handle (a pitcher) intended to hold and facilitate pouring (e.g., for disposal) of body fluids in association with a medical procedure; it is not intended to be connected to irrigation/aspiration devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094992027	GS1	Case	20	In Commercial Distribution
Primary	00630094992020	GS1