PXP-LAVARE - PXP-LAVARE Control Module, packaged - Thermogenesis Corp.

Duns Number:080690327

Device Description: PXP-LAVARE Control Module, packaged

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More Product Details

Catalog Number

-

Brand Name

PXP-LAVARE

Version/Model Number

80121

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK120061,BK120061

Product Code Details

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Device Record Status

Public Device Record Key

ce399ea0-359b-4e79-b0b0-e05880f5fc9b

Public Version Date

October 11, 2021

Public Version Number

1

DI Record Publish Date

October 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERMOGENESIS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 26