Haier - Ultra low temperature freezer - Qingdao Haier Biomedical Co Ltd

Duns Number:529121599

Device Description: Ultra low temperature freezer

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More Product Details

Catalog Number

DW-86L578SAT

Brand Name

Haier

Version/Model Number

DW-86L578SAT

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

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Device Record Status

Public Device Record Key

3f99d2d3-5fde-4f91-8ff9-fc0c4636c3eb

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QINGDAO HAIER BIOMEDICAL CO LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 40