MXP Processing Bagset - Cell separation processing and collection bag set. - Thermogenesis Corp.

Duns Number:080690327

Device Description: Cell separation processing and collection bag set.

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More Product Details

Catalog Number

-

Brand Name

MXP Processing Bagset

Version/Model Number

8-5137

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

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Device Record Status

Public Device Record Key

408c9a53-a5dc-46f8-ab5e-df4b8d152508

Public Version Date

January 12, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10886368000312

Quantity per Package

24

Contains DI Package

00886368000315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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