DISPIRO 02401

GUDID H671024011

BAG, 5 LITER W/ BAG KEEPER

UTAH MEDICAL PRODUCTS, INC.

Gasometer
Primary Device IDH671024011
NIH Device Record Key0e8c3ad3-3d78-4332-a2ab-a330d8fed244
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISPIRO
Version Model Number5 Liter with Keeper
Catalog Number02401
Company DUNS094651270
Company NameUTAH MEDICAL PRODUCTS, INC.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-533-4984
Emailcustomer@utahmed.com

Device Dimensions

Total Volume5 Liter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH671024010 [Unit of Use]
HIBCCH671024011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-18
Device Publish Date2016-09-22

On-Brand Devices [DISPIRO]

H671020091UNIVERSAL MANIFOLD AND TRACH ADAPTOR
H671020021MANOMETER CONNECTOR PRESSURE CAP W/ 14" TUBING
H6710200115 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02401
H67102000110 LITER STANDARD KIT W/ P/N 02002, 02009, 02020, & 02400
H6719502452Disposable Spirometer System Kit with 02401, 02020, 02013
H671025001STANDARD KIT W/ P/N 02002, 02009, & 02010, 02020, NO BAG
H671024611BULK PACK, 5 LITER COLLECTION BAG W/ 22MM CONNECTOR
H671024601BULK PACK, 10 LITER COLLECTION BAG W/ 22MM CONNECTOR
H671024511BULK PACK, 5 LITER COLLECTION BAG W/ UNIVERSAL CONNECTOR
H671024011BAG, 5 LITER W/ BAG KEEPER
H671024001BAG, 10 LITER W/ BAG KEEPER
H67102040122 MM CONNECTOR W/ ONE-WAY VALVE
H671020201MOUTH PIECE W/ DOUBLE ONE-WAY VALVES
H671020131UNIVERSAL CONNECTOR

Trademark Results [DISPIRO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DISPIRO
DISPIRO
73419541 1280628 Dead/Cancelled
Utah Medical Products, Inc.
1983-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.