DISPIRO

Basic Information

• Brand Name: DISPIRO
• Primary DI: H671020001
• Version / Model: 10 Liter Kit
• Catalog Number: 02000
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Labeler DUNS: 094651270
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2019-12-17
• Public Version Status: Update
• Public Device Record Key: d56343a4-4211-4471-87ab-d794b0dc1a98

Device Description

10 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02400

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
Primary	H671020001	HIBCC
Unit of Use	H671020000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K791177	000

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Liter