Biomedix B32 SELEC-3+NIS+LAS IV ADM. SET

Basic Information

• Brand Name: Biomedix B32 SELEC-3+NIS+LAS IV ADM. SET
• Primary DI: 00851470007064
• Version / Model: B32-102
• Company Name: BIOMEDIX-INC
• Labeler DUNS: 798045530
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2023-10-30
• Public Version Status: Update
• Public Device Record Key: a52e1d3b-a1cc-4cad-b83c-5267df70cf99

Device Description

B32 SELEC-3+NIS+LAS IV ADM. SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851470007064	GS1

Premarket Submissions

Submission Number	Supplement Number
K142097	000