Recirculator - The Recirculator 8.0 is comprised of two - Eight Medical International B.V.

Duns Number:490348632

Device Description: The Recirculator 8.0 is comprised of two components: a portable control console and a si

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More Product Details

Catalog Number

-

Brand Name

Recirculator

Version/Model Number

8.0

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102900

Product Code Details

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Device Record Status

Public Device Record Key

6bb30165-5f1c-4752-9ab5-d966409a0aa1

Public Version Date

April 20, 2020

Public Version Number

1

DI Record Publish Date

April 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EIGHT MEDICAL INTERNATIONAL B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2