Hanks' Balanced Salt Solution (HBSS) - LIFE TECHNOLOGIES CORPORATION

Duns Number:118793157

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More Product Details

Catalog Number

-

Brand Name

Hanks' Balanced Salt Solution (HBSS)

Version/Model Number

14175079

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 25, 2022

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

-

Product Code Details

Product Code

KIP

Product Code Name

FORMULATIONS, BALANCED SALT SOLUTIONS

Device Record Status

Public Device Record Key

b8072ed6-1606-4436-97df-c4c270fd103e

Public Version Date

May 26, 2022

Public Version Number

4

DI Record Publish Date

August 04, 2016

Additional Identifiers

Package DI Number

30190302002879

Quantity per Package

6

Contains DI Package

10190302002875

Package Discontinue Date

May 25, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"LIFE TECHNOLOGIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 634
2 A medical device with a moderate to high risk that requires special controls. 77
3 A medical device with high risk that requires premarket approval 12