Split Cath® III - 14F X 32CM Split Cath® III CATHETER ONLY (CUFF - Medical Components, Inc.

Duns Number:038000253

Device Description: 14F X 32CM Split Cath® III CATHETER ONLY (CUFF 27CM FROM TIP)

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More Product Details

Catalog Number

RMS23413

Brand Name

Split Cath® III

Version/Model Number

RMS23413

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

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

MSD

Product Code Name

Catheter, hemodialysis, implanted

Device Record Status

Public Device Record Key

1d7a0575-1303-48ef-920c-272daa5fa00d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2020

Additional Identifiers

Package DI Number

50884908158071

Quantity per Package

10

Contains DI Package

00884908158076

Package Discontinue Date

-

Package Status

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