Catalog Number

8884719012

Brand Name

HUDSON RCI

Version/Model Number

IPN049102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K182847,K182847

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

f6e703d5-b19e-40b3-b1b5-d2783f92f411

Public Version Date

January 22, 2021

Public Version Number

1

DI Record Publish Date

January 14, 2021

Package DI Number

24026704615234

Quantity per Package

12

Contains DI Package

14026704615237

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box