SCU Narrow Cap Sampler Syringe Kit A100727

GUDID 19555240405590

SCU Narrow Cap Sampler Syringe Kit is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For single use only. The device is for use by trained laboratory staff, in a laboratory.

ITL ASIA PACIFIC SDN. BHD.

Blood/blood culture specimen transfer spike IVD
Primary Device ID19555240405590
NIH Device Record Keyd026e59b-fa5a-437d-a007-d567e2742c24
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCU Narrow Cap Sampler Syringe Kit
Version Model NumberA100727
Catalog NumberA100727
Company DUNS597723837
Company NameITL ASIA PACIFIC SDN. BHD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com
Phone+18884112851
Emailsales@itlbiomedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Direct Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS109555240405593 [Primary]
GS119555240405590 [Package]
Contains: 09555240405593
Package: Inner Box [30 Units]
In Commercial Distribution
GS129555240405597 [Package]
Package: Carton [6 Units]
In Commercial Distribution

FDA Product Code

LIBDevice, General Purpose, Microbiology, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-29
Device Publish Date2025-04-21

Devices Manufactured by ITL ASIA PACIFIC SDN. BHD.

19555240405590 - SCU Narrow Cap Sampler Syringe Kit2025-04-29SCU Narrow Cap Sampler Syringe Kit is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For single use only. The device is for use by trained laboratory staff, in a laboratory.
19555240405590 - SCU Narrow Cap Sampler Syringe Kit2025-04-29 SCU Narrow Cap Sampler Syringe Kit is a needleless device used to transfer samples from blood culture bottles for blood culture
09555240404985 - SCU Wide Cap Sampler2024-12-19 SCU Wide Cap Sampler is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For s
19555240401349 - Segment Sampler (SEG)2024-08-08 SEG is intended to aid extraction of a biological fluid sample from a segmented piece of tubing.
09555240404091 - ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS2023-12-19 The tourniquet is a constricting band used to control venous and arterial circulation to an extremity for a period of time. The
19555240401608 - ITL Essentials™ Sharps Passing Tray Large2023-07-27 ITL Essentials™ Sharps Passing Tray Large is the sterile version of Sharps Passing Tray Large which is used for safe transfer
19555240401615 - ITL Essentials™ Sharps Passing Tray Large NS2023-07-27 ITL Essentials™ Sharps Passing Tray Large Non-Sterile is the non-sterile version of Sharps Passing Tray Large which is used fo
19555240405217 - IV Start Kit2023-07-06 IV Start Kit, Sterile is a single sterile disposable procedure packs with various combination of components, such as adhesive dr
19555240401189 - ITL Essentials™ Sharps Passing Tray, Sterile2022-03-22 ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instruments such as surgical scalpels and capped sy

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.