Kit SST-A 10 for PF96 - Kit SST-A for the retrofitting of the Helmer PF96 - BIOLOG-ID

Duns Number:277828187

Device Description: Kit SST-A for the retrofitting of the Helmer PF96 incubator

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More Product Details

Catalog Number

-

Brand Name

Kit SST-A 10 for PF96

Version/Model Number

01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

c8634f4e-6c62-427e-bd97-42dd184537b9

Public Version Date

April 29, 2020

Public Version Number

2

DI Record Publish Date

July 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOLOG-ID" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12