Primary Device ID | 00801741225895 |
NIH Device Record Key | a5e39e31-368a-40e6-85d0-ccc1f7641655 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Site~Rite 8 Ultrasound System |
Version Model Number | SR8v3.0.1 |
Catalog Number | SR8v3.0.1 |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00801741225895 [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 | 2022-06-09 |
Device Publish Date | 2022-06-01 |
00801741161070 | SR8 USv2.0.1 |
00801741155406 | Cue Upgrade Kit (Probe, Activator, Mnt arm) |
00801741155390 | Cue Start Kit (SR8, Probe, Activator, Mnt arm) |
00801741155383 | Site~Rite 8 20mm Cue Linear Probe (Refurbished) |
00801741143809 | Site~Rite 8 Version 2.0.1 |
00801741138324 | Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe |
00801741138317 | Site~Rite 8 Ultrasound System 32mm Linear Probe (Remanufactured) |
00801741138300 | Site~Rite 8 Ultrasound System 32mm Linear Probe (Refurbished) |
00801741138294 | Site~Rite 8 Ultrasound System 32mm Linear Probe |
00801741138287 | Site~Rite 8 Ultrasound System Console (Remanufactured) |
00801741138270 | Site~Rite 8 Ultrasound System Console (Refurbished) |
00801741138263 | Site~Rite 8 Ultrasound System Console |
00801741138256 | Cue Mounting Arm |
00801741138232 | Cue Activator |
00801741138218 | Site~Rite 8 20mm Cue Linear Probe |
00801741138201 | Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe (Remanufactured) |
00801741138195 | Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe (Refurbished) |
00801741225895 | Site~Rite 8 Software v. 3.0.1 |
00801741219382 | Site~Rite 8 Software v. 2.3.1 |