Solution Transfer Device - US005110 I V Solution Transfer Kit - BRACCO DIAGNOSTICS INC

Duns Number:849234661

Device Description: US005110 I V Solution Transfer Kit

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More Product Details

Catalog Number

005110

Brand Name

Solution Transfer Device

Version/Model Number

005110

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"

-

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

20bfeb1d-7221-4a1c-8d75-a27a9871b285

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

30815112020119

Quantity per Package

10

Contains DI Package

10815112020115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"BRACCO DIAGNOSTICS 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. 28