| Primary Device ID | 00616784470429 |
| NIH Device Record Key | 36dd720e-0661-49b6-9d07-ac524f18b4dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IV Start Kit with Nitrile Gloves, Sterile-EO |
| Version Model Number | 4704 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784470429 [Primary] |
| GS1 | 00616784470436 [Package] Package: Case [50 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2025-08-27 |
| Device Publish Date | 2022-01-06 |
| 00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet | 2026-02-03 |
| 00840117348790 - Flavored Oral Swab, For Professional And Hospital use | 2026-01-29 Individually Wrapped |
| 00840117348813 - Unflavored Oral Swab, For Professional and Hospital Use | 2026-01-29 Individually Wrapped |
| 00840117348837 - Oral Swabsticks, Flavored w/Dentrifice | 2026-01-29 |
| 00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use | 2026-01-29 |
| 00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal | 2026-01-13 |
| 00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal | 2026-01-13 |
| 00840117344136 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter,30.5 cm/12in, 12 FR (4.0 mm) | 2026-01-13 STERILE-EO, CONTENT: 1. Catheter, 1. MDI Adaptor, 1. 15 mm Swivel Adaptor, 1. 22 mm Flex Tube, 1. 15 mm x 22 mm Adaptor, 1. Tra |