AIV

Basic Information

• Brand Name: AIV
• Primary DI: M745BX10469
• Version / Model: BX10469
• Catalog Number: BX10469
• Company Name: AMERICAN IV PRODUCTS, INC.
• Labeler DUNS: 181184474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-09-23
• Public Version Status: Update
• Public Device Record Key: 9c34dc1b-555b-4766-8ffe-3d85b0999009

Device Description

Assembly Door 1 Baxter

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17634	Bedside infusion pump, multichannel	An electrically-powered, non-ambulatory (bedside) device designed to facilitate the simultaneous, accurate, and consistent administration of multiple drugs/solutions (multichannel) from a standard infusion bag or bottle, via intravenous, subcutaneous, arterial, epidural, and intracavital routes, using a dedicated infusion set. It is not dedicated to a specific treatment type and is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M745BX10469	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K032789	000

Device Sizes

Type	Value	Unit	Text
Height	0.842	Inch
Width	2.75	Inch
Length	8.325	Inch