| Primary Device ID | 00850042365007 |
| NIH Device Record Key | 80eb8b2f-f89a-446b-b111-a8d1f8e3e584 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 20G Open-System Ally Blood Collection Device |
| Version Model Number | AV100000 |
| Company DUNS | 106772781 |
| Company Name | Avia Vascular, LLC |
| 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 |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Outer Diameter | 0.0274 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850042365007 [Primary] |
| GS1 | 10850042365004 [Package] Package: Inner Pack [8 Units] In Commercial Distribution |
| GS1 | 20850042365001 [Package] Contains: 10850042365004 Package: Case [4 Units] In Commercial Distribution |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-01 |
| Device Publish Date | 2022-10-24 |
| 10850042365059 - 20G 8CM Stiletto Extended Dwell Catheter | 2024-07-03 The Stiletto Extended Dwell Catheter (EDC) is a sterile, single use device designed to allow users to sample blood and/or admini |
| 00850042365007 - 20G Open-System Ally Blood Collection Device | 2022-11-01 |
| 00850042365007 - 20G Open-System Ally Blood Collection Device | 2022-11-01 |
| 00850042365014 - 22G Open-System Ally Blood Collection Device | 2022-11-01 |