MeDS Pump - 2008 MeDS Pump Tubing Set - Fresenius Medical Care Holdings, Inc.

Duns Number:958291411

Device Description: 2008 MeDS Pump Tubing Set

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More Product Details

Catalog Number

04-7103-7

Brand Name

MeDS Pump

Version/Model Number

04-7103-7

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 06, 2019

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

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Device Record Status

Public Device Record Key

629e0797-cc56-46f7-bb90-4087b8c00790

Public Version Date

October 11, 2022

Public Version Number

4

DI Record Publish Date

September 30, 2015

Additional Identifiers

Package DI Number

10840861100498

Quantity per Package

100

Contains DI Package

00840861100491

Package Discontinue Date

September 06, 2019

Package Status

Not in Commercial Distribution

Package Type

Case

"FRESENIUS MEDICAL CARE HOLDINGS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65