AIV

Basic Information

• Brand Name: AIV
• Primary DI: M745FM10839
• Version / Model: FM10839
• Catalog Number: FM10839
• Company Name: AMERICAN IV PRODUCTS, INC.
• Labeler DUNS: 181184474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 31d5a5ef-1e07-4626-a785-9dba61ca5f03

Device Description

Fetal Transducer Coro Toco Belt

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	884.2720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37258	Tocodynamometer probe	A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M745FM10839	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K040392	000

Device Sizes

Type	Value	Unit	Text
Length	122.75	Inch
Height	0.8	Inch
Outer Diameter	2.75	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 140 Degrees Fahrenheit