XVIVO Click Adapter - Intended as an adapter between the Perfadex® Plus - Xvivo Perfusion AB

Duns Number:559895730

Device Description: Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spi Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike.

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More Product Details

Catalog Number

19125

Brand Name

XVIVO Click Adapter

Version/Model Number

19125

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

NEP

Product Code Name

System/Device, Pharmacy Compounding

Device Record Status

Public Device Record Key

41f0e0fb-c712-47cb-b673-e7385a8f30d9

Public Version Date

April 23, 2019

Public Version Number

3

DI Record Publish Date

September 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XVIVO PERFUSION AB" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9
3 A medical device with high risk that requires premarket approval 7