DISPIRO - STANDARD KIT W/ P/N 02002, 02009, & 02010, 02020, - UTAH MEDICAL PRODUCTS, INC.

Duns Number:094651270

Device Description: STANDARD KIT W/ P/N 02002, 02009, & 02010, 02020, NO BAG

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More Product Details

Catalog Number

02500

Brand Name

DISPIRO

Version/Model Number

Kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K791177,K791177

Product Code Details

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Device Record Status

Public Device Record Key

af3201ea-c9eb-4e64-892c-32b1bb9ebac9

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UTAH MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 274