BladderScan® 0570-0346
GUDID 00879123004499
VERATHON INC
Bladder volume ultrasound imaging system| Primary Device ID | 00879123004499 |
| NIH Device Record Key | 0b9abb07-ce18-43d5-8ae5-62f4fb92d6d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BladderScan® |
| Version Model Number | Prime |
| Catalog Number | 0570-0346 |
| Company DUNS | 130598584 |
| Company Name | VERATHON 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 | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00879123004499 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153101
FDA Product Code
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [BladderScan®]
Trademark Results [BladderScan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BLADDERSCAN 78174469 2829901 Live/Registered |
VERATHON INC. 2002-10-15 |
 BLADDERSCAN 74216827 not registered Dead/Abandoned |
Diagnostic Ultrasound Corporation 1991-10-29 |
 BLADDERSCAN 73793955 not registered Dead/Abandoned |
DIAGNOSTIC ULTRASOUND CORPORATION 1989-04-17 |
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