Set, I.V. Fluid Transfer - MPS MEDICAL, INC

Duns Number:079636164

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Set, I.V. Fluid Transfer

Version/Model Number

3 PHARM-6

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

K850757

Product Code Details

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Device Record Status

Public Device Record Key

fdd49730-cb91-4eed-9689-f06c0023f5eb

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

May 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MPS MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 148