Curaplex - VibraPEP Oscillatory PEP Therapy Device - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: VibraPEP Oscillatory PEP Therapy Device

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More Product Details

Catalog Number

301-44F50-100

Brand Name

Curaplex

Version/Model Number

301-44F50-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K163091,K163091,K163091

Product Code Details

Product Code

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Device Record Status

Public Device Record Key

8ca11344-21a0-4cb9-9a60-d8b972162b08

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 30, 2022

Additional Identifiers

Package DI Number

00810094573126

Quantity per Package

12

Contains DI Package

00810094573102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"BOUND TREE MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 471
2 A medical device with a moderate to high risk that requires special controls. 540
3 A medical device with high risk that requires premarket approval 3
U Unclassified 1