Transfer Device - Two-Way Transfer Device, Non-DEHP (previously - ICU MEDICAL FLEET SERVICES, LLC

Duns Number:830767898

Device Description: Two-Way Transfer Device, Non-DEHP (previously Hospira product)

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More Product Details

Catalog Number

0300204

Brand Name

Transfer Device

Version/Model Number

300204

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

GBX

Product Code Name

CATHETER, IRRIGATION

Device Record Status

Public Device Record Key

691fb2bf-6cef-4cc1-94a2-f60e09f11e81

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

May 31, 2018

Additional Identifiers

Package DI Number

20887787006470

Quantity per Package

400

Contains DI Package

10887787006473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"ICU MEDICAL FLEET SERVICES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2