Barkey S-line - The device delivers warm blood, blood products, - Barkey GmbH & Co. KG

Duns Number:312555782

Device Description: The device delivers warm blood, blood products, and liquids to adult and pediatric patient The device delivers warm blood, blood products, and liquids to adult and pediatric patients

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More Product Details

Catalog Number

-

Brand Name

Barkey S-line

Version/Model Number

39 °C

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

K213191

Product Code Details

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Device Record Status

Public Device Record Key

86ac296b-d49d-4899-8ff7-8e05cb40687a

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BARKEY GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6