| Primary Device ID | 19555240401127 |
| NIH Device Record Key | 0e423a09-752d-4fda-baa8-2487d9a1b4ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safety SubCulture Unit (SCU) |
| Version Model Number | A100720 |
| Catalog Number | A100720 |
| Company DUNS | 597723837 |
| Company Name | ITL ASIA PACIFIC SDN. BHD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com | |
| Phone | +18884112851 |
| sales@itlbiomedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Direct Sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 19555240400038 [Package] Package: Carton [6 Units] In Commercial Distribution |
| GS1 | 19555240401110 [Primary] |
| GS1 | 19555240401127 [Package] Contains: 19555240401110 Package: Inner Box [60 Units] In Commercial Distribution |
| LIB | Device, General Purpose, Microbiology, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-01-22 |
| Device Publish Date | 2020-09-19 |
| 09555240404091 - ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS | 2023-12-19 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 Large | 2023-07-27 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 NS | 2023-07-27 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 Kit | 2023-07-06 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, Sterile | 2022-03-22 ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instruments such as surgical scalpels and capped sy |
| 19555240400083 - TiMO™ Tube Management Holder | 2021-06-28 TiMO™ is intended as a sample test tube holder to assist with the management of the sample tubes during blood collection. |
| 19555240401127 - Safety SubCulture Unit (SCU) | 2021-01-22SCU is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick injury. |
| 19555240401127 - Safety SubCulture Unit (SCU) | 2021-01-22 SCU is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick |
| 19555240401448 - Safety SubCulture Unit 2 (SCU2) | 2021-01-22 SCU2 is a needleless device used to obtain samples from blood culture bottles and to prevent the risk of a potential needlestick |