| Primary Device ID | 10015482263161 |
| NIH Device Record Key | db9624bb-7cba-465c-8172-90597f4061de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TechLITE Insulin Syringes 1mL 31G x 15/64" (6mm) |
| Version Model Number | 260316 |
| Company DUNS | 008171162 |
| Company Name | ARKRAY USA, INC. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx | |
| Phone | 1-800-818-8877 |
| xxx@xxx.xxx |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 1 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00015482263164 [Package] Contains: 00015482613167 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 00015482613167 [Primary] |
| GS1 | 10015482263161 [Package] Contains: 00015482263164 Package: Master Shipper [10 Units] In Commercial Distribution |
| GS1 | 50015482613162 [Unit of Use] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-07-28 |
| Device Publish Date | 2018-01-09 |
| 00015482510060 - Assure® Control - Control Solution Level 2 & Level 3 | 2025-10-06 For use with the Assure Titanium Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the mete |
| 00015482600013 - Assure® Titanium Blood Glucose Meter | 2025-09-23 The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposabl |
| 10015482600508 - Assure® Titanium Blood Glucose Test Strips | 2025-09-23 The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposabl |
| 10015482601000 - Assure® Titanium Blood Glucose Test Strips | 2025-09-23 The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposabl |
| 10015482102910 - ASSURE® ID Insulin 1cc Safety Syringe | 2025-03-19 Sterile Safety Syringe |
| 10015482102958 - ASSURE® ID Insulin 0.5cc Safety Syringe | 2025-03-19 Sterile Safety Syringe |
| 00015482117313 - AUTION MAX™ AX-4060 Analyzer | 2024-12-10 The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intend |
| 00015482117344 - AUTION™ Sticks 9EB - Test Strips | 2024-12-10 AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following ana |