FDA.reportPublic FDA data

TiMO™ Tube Management Holder

Primary DI
19555240400083
Brand
TiMO™ Tube Management Holder
Company
ITL ASIA PACIFIC SDN. BHD.
Model
C100400
Device description
TiMO™ is intended as a sample test tube holder to assist with the management of the sample tubes during blood collection.
Published
2021-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19555240400083PrimaryGS10
09555240400086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955524040008319555240400083
09555240400086095552404000869555240400086

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/analyser test tube rack IVDA device intended to hold test tubes or other containers on board an in vitro diagnostic laboratory instrument or analyser. It is typically made of plastic or metal, with slots or holes in which the test tubes or containers are placed.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18884112851sales@itlbiomedical.com

Regulatory Flags#

DUNS number
597723837
Device count
1500
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09555240406361Cell Culture Sampler Wide Cap 2mLA100780A1007802026-06-23
09555240404992SCU Narrow Cap SamplerA100724A1007242025-06-04
09555240405616SampLok® Sampling Kit 16mLA100756A1007562025-06-04
19555240404999SCU Narrow Cap SamplerA100724A1007242025-06-04
19555240405613SampLok® Sampling Kit 16mLA100756A1007562025-06-04
09555240400536SampLok® Sampling Kit 16mLA100740A1007402019-03-29
09555240400734SampLok® Sampling Kit 10mLA100750A1007502019-03-29
09555240403865SampLok® Sampling Kit 35mLA100752A1007522019-08-21
09555240404084SampLok® Sampling Kit 20mLA100754A1007542020-02-29
09555240405593SCU Narrow Cap Sampler Syringe KitA100727A1007272025-04-21
19555240401110Safety SubCulture Unit (SCU)A100720A1007202020-09-19
19555240401400Transfer Cap SetA100730A1007302020-02-29
19555240401431Safety SubCulture Unit 2 (SCU2)A100722A1007222020-09-19
09555240404985SCU Wide Cap SamplerA100723A1007232024-12-11
19555240405590SCU Narrow Cap Sampler Syringe KitA100727A1007272025-04-21
09555240401304SampLok® Adapter Cap 2A100718A1007182019-03-29
09555240401540SampLok® Adapter Cap 3A100762A1007622019-03-29
09555240401557SampLok® Adapter Cap 3 InsertA100763A1007632019-03-29
19555240400014SampLok® Adapter Cap InsertA100709A1007092019-03-29
19555240401080ITL Essentials™ Needle Mat (Sterile)A500101A5001012020-09-20

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