MediFlo - MEDIFLO 250ML VOL/50ML HR 24/CS - NDC HOMECARE LLC

Duns Number:939966016

Device Description: MEDIFLO 250ML VOL/50ML HR 24/CS

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More Product Details

Catalog Number

MDE250050

Brand Name

MediFlo

Version/Model Number

MDE250050

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

K151650,K151650

Product Code Details

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Device Record Status

Public Device Record Key

a1f7dd38-af25-46a7-bb18-b7082f2f7198

Public Version Date

December 01, 2020

Public Version Number

1

DI Record Publish Date

November 23, 2020

Additional Identifiers

Package DI Number

10850007185166

Quantity per Package

24

Contains DI Package

00850007185169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NDC HOMECARE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 28