Beeline motIV - Dual Catheter Kit: Standard 3 hole catheter with - Rex Pj Tech LLC

Duns Number:096931706

Device Description: Dual Catheter Kit: Standard 3 hole catheter with 4'' split sheath introducer

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More Product Details

Catalog Number

-

Brand Name

Beeline motIV

Version/Model Number

YK2

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)

-

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

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

4d9b79c7-6c41-4e6a-b5b2-70cfca63c626

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Additional Identifiers

Package DI Number

10857362007232

Quantity per Package

12

Contains DI Package

00857362007235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard box

"REX PJ TECH LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22