Curaplex - Pneumofix 8 Decompression Kit - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: Pneumofix 8 Decompression Kit

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More Product Details

Catalog Number

670188-KIT

Brand Name

Curaplex

Version/Model Number

670188-KIT

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"

-

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

-

Product Code Details

Product Code

KGZ

Product Code Name

ACCESSORIES, CATHETER

Device Record Status

Public Device Record Key

b5b82ce9-42d7-4403-bd62-c8d93392cf8b

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

00810094571252

Quantity per Package

25

Contains DI Package

00812277036299

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