| Primary Device ID | 00810160810049 |
| NIH Device Record Key | d2165727-41a6-4a32-bb62-c45356cc23a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Red Tunica |
| Version Model Number | RT-34148 |
| Catalog Number | RT-34148 |
| Company DUNS | 785417726 |
| Company Name | Rodimedi & Associates, Inc. |
| Device Count | 1 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM | |
| Phone | +1 (888) 315-9472 |
| JRODRIGUEZ@RODIMEDI.COM |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Needle Gauge | 20 Gauge |
| Length | 38 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810160810032 [Primary] |
| GS1 | 00810160810049 [Package] Contains: 00810160810032 Package: Inner Box [100 Units] In Commercial Distribution |
| GS1 | 00810160810056 [Package] Package: Case [10000 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-24 |
| Device Publish Date | 2024-06-14 |
| 00850036464815 | RedTunica™ Disposable Hypodermic Needle 27G x 1-1/2" - Sterile hypodermic needles intended to |
| 00810160810162 | RedTunica™ Disposable Hypodermic Needle 25G x 5/8" - Sterile hypodermic needles intended to in |
| 00810160810131 | RedTunica™ Disposable Hypodermic Needle 23G x 1" - Sterile hypodermic needles intended to inje |
| 00810160810100 | RedTunica™ Disposable Hypodermic Needle 22G x 1-1/2" - Sterile hypodermic needles intended to |
| 00810160810070 | RedTunica™ Disposable Hypodermic Needle 21G x 1-1/2" - Sterile hypodermic needles intended to |
| 00810160810049 | RedTunica™ Disposable Hypodermic Needle 20G x 1-1/2" - Sterile hypodermic needles intended to |
| 00810160810018 | RedTunica™ Disposable Hypodermic Needle 18G x 1-1/2" - Sterile hypodermic needles intended to |
| 20850036464666 | The RedTunica™ One Step iFOB is a rapid immunoassay for the qualitative detection of human occ |
| 10810160810411 | RedTunica™ SediRedi™ - Autozero Westergren ESR System is a quantitative, non-specific, eryth |
| 00810160810360 | The RedTunica™ RSV Antigen Test is a rapid immunochromatographic assay for the qualitative det |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RED TUNICA 97246888 not registered Live/Pending |
Rodimedi & Associates, Inc, 2022-01-31 |