| Primary Device ID | 00801741225772 |
| NIH Device Record Key | ab2fb390-12d0-494f-a069-52db23ac63ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Site Rite 8 Ultrasound System |
| Version Model Number | SR8v3.1.0 |
| Catalog Number | SR8v3.1.0 |
| Company DUNS | 044611812 |
| Company Name | Bard Access Systems, 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741225772 [Primary] |
| LLZ | System, image processing, radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-26 |
| Device Publish Date | 2023-09-18 |
| 00801741225772 | Site Rite 8 Ultrasound System |
| 00801741219405 | Site Rite 8 Ultrasound System Application Software |
| 00801741219313 | Site Rite 8 Ultrasound System Host Application Software |