Patient Monitor
GUDID 06944413815889
Edan Instruments, Inc.
General-purpose multi-parameter bedside monitor| Primary Device ID | 06944413815889 |
| NIH Device Record Key | c967c08e-4e22-4de1-97bb-c2efee017b3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patient Monitor |
| Version Model Number | iX10 |
| Company DUNS | 529173163 |
| Company Name | Edan Instruments, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 06944413815889 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232962
FDA Product Code
| MLD | Monitor, St Segment With Alarm |
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 | 2024-06-25 |
| Device Publish Date | 2024-06-17 |
On-Brand Devices [Patient Monitor]
| 06944413808119 | PM-2000A+ |
| 06944413806726 | PM-2000M |
| 06944413806696 | MM17 |
| 06944413806665 | PM-2000XL Plus |
| 06944413806658 | PM-2000XL |
| 06944413806641 | PM-2000XL Pro |
| 06944413806634 | PM-2000A Pro |
| 06944413806627 | PM-2000A |
| 06944413802179 | iM20 |
| 06944413802162 | elite V6 |
| 06944413802155 | elite V5 |
| 06944413801844 | iM70 |
| 06944413801837 | iM60 |
| 06944413801707 | elite V8 |
| 06944413801646 | iM80 |
| 06944413801622 | iM50 |
| 06944413801615 | iM8B |
| 06944413801608 | iM8A |
| 06944413801592 | iM8 |
| 06944413800823 | M50 |
| 06944413800816 | M80 |
| 06944413810945 | X12 |
| 06944413810921 | X10 |
| 06944413810907 | X8 |
| 06944413814769 | X12s |
| 06944413814752 | X8s |
| 06944413814387 | X10s |
| 06944413815902 | iX15 |
| 06944413815896 | iX12 |
| 06944413815889 | iX10 |
Trademark Results [Patient Monitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |
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