| Primary Device ID | 00816734022924 |
| NIH Device Record Key | d14da0a6-f0af-4627-8890-f80e7dee93b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zvu® |
| Version Model Number | HRAM-200-17-KIT |
| Catalog Number | HRAM-200-17-KIT |
| Company DUNS | 030650113 |
| Company Name | DIVERSATEK HEALTHCARE, 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 | 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 | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com |
| Catheter Gauge | 17 French |
| Catheter Gauge | 17 French |
| Catheter Gauge | 17 French |
| Catheter Gauge | 17 French |
| Catheter Gauge | 17 French |
| Catheter Gauge | 17 French |
| Catheter Gauge | 17 French |
| Catheter Gauge | 17 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816734022924 [Primary] |
| FFX | System, Gastrointestinal Motility (Electrical) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816734022924]
High-level Disinfectant
[00816734022924]
High-level Disinfectant
[00816734022924]
High-level Disinfectant
[00816734022924]
High-level Disinfectant
[00816734022924]
High-level Disinfectant
[00816734022924]
High-level Disinfectant
[00816734022924]
High-level Disinfectant
[00816734022924]
High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-09 |
| Device Publish Date | 2020-10-30 |
| 00816734022924 | Zvu® HRAM Starter Kit |
| 00816734022917 | Zvu® HRiM Probe Kit |
| 00816734022863 | Zvu® Anorectal Manometry Procedure Kit |
| 00816734022856 | Zvu® Anorectal Balloons |
| 00816734022740 | HRAM Protocol for BioView |
| 00816734022733 | Zvu® HRAM Probe |
| 00816734022689 | Zvu® HRiM Probe |
| 00816734022894 | Replacement Cable for Zvu® HRiM and HRaM Probes |
| 00816734023426 | Zvu® Functional GI Software Revision 3.4.0 |