DISPIRO 02000

GUDID H671020001

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

UTAH MEDICAL PRODUCTS, INC.

Gasometer

• Primary Device ID: H671020001
• NIH Device Record Key: d56343a4-4211-4471-87ab-d794b0dc1a98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPIRO
• Version Model Number: 10 Liter Kit
• Catalog Number: 02000
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-533-4984
• Email: customer@utahmed.com

Device Dimensions

• Total Volume: 10 Liter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671020000 [Unit of Use]
HIBCC	H671020001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791177

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-17
• Device Publish Date: 2016-09-22

On-Brand Devices [DISPIRO]

• H671020091: UNIVERSAL MANIFOLD AND TRACH ADAPTOR
• H671020021: MANOMETER CONNECTOR PRESSURE CAP W/ 14" TUBING
• H671020011: 5 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02401
• H671020001: 10 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02400
• H6719502452: Disposable Spirometer System Kit with 02401, 02020, 02013
• H671025001: STANDARD KIT W/ P/N 02002, 02009, & 02010, 02020, NO BAG
• H671024611: BULK PACK, 5 LITER COLLECTION BAG W/ 22MM CONNECTOR
• H671024601: BULK PACK, 10 LITER COLLECTION BAG W/ 22MM CONNECTOR
• H671024511: BULK PACK, 5 LITER COLLECTION BAG W/ UNIVERSAL CONNECTOR
• H671024011: BAG, 5 LITER W/ BAG KEEPER
• H671024001: BAG, 10 LITER W/ BAG KEEPER
• H671020401: 22 MM CONNECTOR W/ ONE-WAY VALVE
• H671020201: MOUTH PIECE W/ DOUBLE ONE-WAY VALVES
• H671020131: UNIVERSAL CONNECTOR