Welch Allyn, Inc.

Basic Information

• Brand Name: Welch Allyn, Inc.
• Primary DI: 00732094196610
• Version / Model: 901058
• Catalog Number: 75MX
• Company Name: WELCH ALLYN, INC.
• Labeler DUNS: 198227881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-30
• Public Version: 1
• Public Version Date: 2021-10-08
• Public Version Status: New
• Public Device Record Key: 650753c0-afa8-4fa6-a919-e046d359a97d

Device Description

WIFI CSM NIBP Masimo

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: No
• 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: No
• 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
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57963	Prostate electrolytic therapy system catheter	A non-sterile, flexible tube with a balloon at its distal end designed to be used together with a prostate electrolytic therapy system to treat benign prostatic hyperplasia (BPH) and prostatitis through transurethral electrochemical treatment causing liquefaction necrosis to the diseased peri-urethral prostate. It typically consists of a single lumen tube with therapeutic electrodes spaced along its outer surface, an inflatable balloon, and holes for the introduction of an ionic solution (e.g., saline mixed with antibiotics) and drainage of discharged fluids/deciduous tissue at the working end, and connectors at the proximal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00732094209365	GS1		1	In Commercial Distribution
Primary	00732094196610	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]