CORFLO cuBBy LPGD - Low profile gastrostomy device kit - CORPAK MEDSYSTEMS, INC.

Duns Number:147530323

Device Description: Low profile gastrostomy device kit

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

35-1615

Brand Name

CORFLO cuBBy LPGD

Version/Model Number

35-1615

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Record Status

Public Device Record Key

79510419-ef93-4c34-9d5e-455250550533

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

August 04, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORPAK MEDSYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 499