DISPIRO

Basic Information

• Brand Name: DISPIRO
• Primary DI: H6719502450
• Version / Model: Custom
• Catalog Number: 950-245
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2019-12-18
• Public Version Status: Update
• Public Device Record Key: 70f2292d-ae16-40ac-9858-069bbea3c2c4

Device Description

Disposable Spirometer System Kit with 02401, 02020, 02013

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BZG	Spirometer, Diagnostic	Anesthesiology	868.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11850	Gasometer	A calibrated container that is usually balanced over water and intended to measure lung gas volumes. Also known as a wet spirometer. This GMDN code reflects old technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H6719502452	HIBCC	Overpack	4	In Commercial Distribution
Package	H6719502451	HIBCC	Box	25	In Commercial Distribution
Primary	H6719502450	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K791177	000