Coiled PD Catheter - 15F X 57.5CM COILED PERITONEAL DIALYSIS CATHETER - Medical Components, Inc.

Duns Number:038000253

Device Description: 15F X 57.5CM COILED PERITONEAL DIALYSIS CATHETER SET W/2 CUFFS

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More Product Details

Catalog Number

-

Brand Name

Coiled PD Catheter

Version/Model Number

MPD-257

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 28, 2018

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

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

FJS

Product Code Name

CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Record Status

Public Device Record Key

1034d205-a879-4f6d-9812-9a315d9e9e52

Public Version Date

August 17, 2018

Public Version Number

4

DI Record Publish Date

November 17, 2015

Additional Identifiers

Package DI Number

50884908030872

Quantity per Package

5

Contains DI Package

00884908030877

Package Discontinue Date

June 28, 2018

Package Status

Not in Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560