| Primary Device ID | 10015482263147 |
| NIH Device Record Key | c83d280b-795f-423c-a1af-ec788d025802 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm) |
| Version Model Number | 260314 |
| 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 | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Total Volume | 0.3 Milliliter |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00015482263140 [Package] Contains: 00015482613143 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 00015482613143 [Primary] |
| GS1 | 10015482263147 [Package] Contains: 00015482263140 Package: Master Shipper [10 Units] In Commercial Distribution |
| GS1 | 50015482613148 [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 |
| 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 |
| 00015482181550 - AUTION EYE™ Sheath Solution - 10L Bottle | 2024-12-10 AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed parti |
| 00015482181574 - AUTION EYE™ Control Solution H/L | 2024-12-10 AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the |
| 00015482181598 - AUTION EYE™ Calibrator Focus/Calibrator | 2024-12-10 AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510. |
| 00015482188627 - AUTION EYE™ AI-4510 Analyzer | 2024-12-10 The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. |
| 14987486005299 - Concentrated Washing Solution 3 | 2024-12-10 A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated ins |
| 00015482183103 - SPOTCHEM™ EZ Analyzer | 2024-05-31 Dry Chemistry Analyzer IVD, semi-automated |