BioCryo Sequential Circulator - Bio Compression Systems, Inc

Duns Number:101393924

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More Product Details

Catalog Number

-

Brand Name

BioCryo Sequential Circulator

Version/Model Number

SC-2004-DL-OTC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Device Record Status

Public Device Record Key

25b2a182-a52e-4425-85b6-42e01bf8bcea

Public Version Date

April 21, 2022

Public Version Number

1

DI Record Publish Date

April 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO COMPRESSION SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 235