SAHARA - Warming equipment with passive agitation plate - Transmed Medizintechnik GmbH & Co. KG

Duns Number:320762776

Device Description: Warming equipment with passive agitation plate for thawing and warming of up to 6 blood co Warming equipment with passive agitation plate for thawing and warming of up to 6 blood components packed in plastic bags

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More Product Details

Catalog Number

97.8710.802

Brand Name

SAHARA

Version/Model Number

SAHARA-III MAXITHERM 115V

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

-

Product Code Details

Product Code

KZL

Product Code Name

Device, Warming. Blood And Plasma

Device Record Status

Public Device Record Key

c6eb91c9-ee49-4d14-885c-69a8c33ce950

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

August 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRANSMED MEDIZINTECHNIK GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 3