Catalog Number

1750

Brand Name

HUDSON RCI

Version/Model Number

IPN042769

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K781831,K781831

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

98f61264-ca75-4f87-b4d3-dcec85100192

Public Version Date

November 04, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

24026704595536

Quantity per Package

10

Contains DI Package

04026704595532

Package Discontinue Date

September 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Box