Patient Monitor
GUDID 06938368100350
General Meditech. Inc.
Cardiac arrhythmia monitoring system| Primary Device ID | 06938368100350 |
| NIH Device Record Key | eb027b80-fa22-45fb-b500-8a92736238fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patient Monitor |
| Version Model Number | G3G |
| Company DUNS | 545261786 |
| Company Name | General Meditech. 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06938368100350 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092970
FDA Product Code
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2024-09-03 |
On-Brand Devices [Patient Monitor]
Trademark Results [Patient Monitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.