DIGNITY® - 8F PLASTIC DIGNITY® MID-SIZED CT PORT - Medical Components, Inc.

Duns Number:038000253

Device Description: 8F PLASTIC DIGNITY® MID-SIZED CT PORT W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER W/5F 8F PLASTIC DIGNITY® MID-SIZED CT PORT W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER W/5F Micro-Stick® INTRODUCER SET

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More Product Details

Catalog Number

MIDP80AMN

Brand Name

DIGNITY®

Version/Model Number

MIDP80AMN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

5a966f6c-4dd0-4e19-a5e8-b37958757735

Public Version Date

November 29, 2019

Public Version Number

1

DI Record Publish Date

November 21, 2019

Additional Identifiers

Package DI Number

50884908149567

Quantity per Package

5

Contains DI Package

00884908149562

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