HUDSON RCI - VOLUMETRIC EXERCISER For Maintaining and - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: VOLUMETRIC EXERCISER For Maintaining and Improving Inspiratory Volume and Respiratory Fitn VOLUMETRIC EXERCISER For Maintaining and Improving Inspiratory Volume and Respiratory Fitness

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More Product Details

Catalog Number

8884719025

Brand Name

HUDSON RCI

Version/Model Number

IPN049318

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

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

K801199,K801199,K801199

Product Code Details

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Device Record Status

Public Device Record Key

f3193082-db0c-4389-84a9-6a9b2b56a520

Public Version Date

August 19, 2020

Public Version Number

2

DI Record Publish Date

August 10, 2018

Additional Identifiers

Package DI Number

34026704630197

Quantity per Package

12

Contains DI Package

14026704630193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26