TiMO™ Tube Management Holder - TiMO™ is intended as a sample test tube holder to - ITL ASIA PACIFIC SDN. BHD.

Duns Number:597723837

Device Description: TiMO™ is intended as a sample test tube holder to assist with the management of the sample TiMO™ is intended as a sample test tube holder to assist with the management of the sample tubes during blood collection.

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More Product Details

Catalog Number

-

Brand Name

TiMO™ Tube Management Holder

Version/Model Number

C100400

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

Yes

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

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Device Record Status

Public Device Record Key

4a7d8566-a7e1-4d56-b3b4-94022873e764

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ITL ASIA PACIFIC SDN. BHD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 5