OptoMonitor F2020
GUDID 07540184020201
Opsens Inc
Image display monitor, colour| Primary Device ID | 07540184020201 |
| NIH Device Record Key | 65c322cc-98d2-431a-9b15-178ed2867317 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptoMonitor |
| Version Model Number | Display Unit |
| Catalog Number | F2020 |
| Company DUNS | 253717946 |
| Company Name | Opsens 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 |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540184020201 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142598
FDA Product Code
| DQX | Wire, Guide, Catheter |
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 [OptoMonitor]
| 07540184020300 | Handle Unit |
| 07540184020201 | Display Unit |
| 07540184020102 | Optical Unit |
| 07540184020010 | OpM OU‐DU Communication cable |
| 07540184012138 | Pd Interface cable to Siemens Recor |
| 07540184012121 | Pd Interface cable to McK/Merge |
| 07540184012114 | Pd Interface cable to Qynetiq |
| 07540184012107 | Pd Interface cable ‐ Bard Clearsign |
| 07540184012091 | Pd interface Mennen Model 267 |
| 07540184012053 | Pd Interface cable to GE CLAB II Plus |
| 07540184012046 | Pd Interface cable to Philips XPER FC |
| 07540184012039 | Pd interface cable ‐ Siemens Axiom Sensis |
| 07540184012022 | Pd Interface cable to GE TRAM |
| 07540184012015 | Pd Interface Cable ‐ Philips/Witt |
| 07540184011124 | Pa input cable - Siemens Axiom Sensis output 1 |
| 07540184011117 | Pa input cable - GE TRAM 450SL |
| 07540184011100 | Pa input cable ‐ PDM |
| 07540184011094 | Pa input cable ‐ Jack 3.5mm |
| 07540184011087 | Pa input cable Mennen CFE |
| 07540184011070 | Pa input cable Siemens Sensis iSIB |
| 07540184011063 | Pa input cable Mennen model 267 |
| 07540184011056 | Pa input cable D15 GE TRAM |
| 07540184011049 | Pa input cable GE TRAM |
| 07540184011032 | Pa input cable ‐ Jack 1/4" |
| 07540184011025 | Pa input cable ‐ Siemens Axiom Sensis |
| 07540184011018 | Pa input cable ‐ BNC |
| 07540184010042 | AC Power cord |
| 07540184010035 | Power supply |
| 07540184023226 | OpM3-DU Wireless dongle |
Trademark Results [OptoMonitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTOMONITOR 86384225 5069180 Live/Registered |
OPSENS INC. 2014-09-03 |
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