SmartHeart 11-50L
GUDID 10845717006818
SmartHeart Talking Pulse Oximeter
VERIDIAN HEALTHCARE LLC
Pulse oximeter probe, reusable| Primary Device ID | 10845717006818 |
| NIH Device Record Key | 4ce0e390-14c4-453f-ae70-d7db42f0dc2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartHeart |
| Version Model Number | 11-50L |
| Catalog Number | 11-50L |
| Company DUNS | 830437997 |
| Company Name | VERIDIAN HEALTHCARE LLC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845717006811 [Primary] |
| GS1 | 10845717006818 [Package] Contains: 30845717006812 Package: Master Shipper [24 Units] In Commercial Distribution |
| GS1 | 30845717006812 [Package] Contains: 00845717006811 Package: INTERMEDIATE [3 Units] In Commercial Distribution |
FDA Product Code
| DQA | Oximeter |
| OCH | Oximeter, Infrared, Sporting, Aviation |
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 | 2019-05-10 |
| Device Publish Date | 2019-05-02 |
On-Brand Devices [SmartHeart]
| 00845717015561 | SmartHeart Automatic Wrist Digital BP Uni |
| 00845717009034 | SmartHeart Automatic Wrist Digital BP Monitor |
| 00845717008891 | SmartHeart Automatic Wrist Digital BP Unit |
| 00845717008884 | SmartHeart Premium Talking Automatic Wrist Digital BP Monitor |
| 00845717008839 | Premium Talking Automatic Digital BP Monitor |
| 00845717006798 | Digital Wrist BP Monitor |
| 10845717115015 | SmartHeart Economy Pulse Oximeter - Walmart special packing |
| 10845717015469 | SmartHeart Talking Wrist Digital Blood Pressure Monitor |
| 10845717008843 | SmartHeart Ultra Premium Automatic Arm Digital BP Monitor |
| 10845717006818 | SmartHeart Talking Pulse Oximeter |
| 30845717009202 | SmartHeart Auto Digital BP Monitor, Wide Range Cuff |
Trademark Results [SmartHeart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTHEART 86896543 not registered Live/Pending |
Veridian Healthcare, LLC 2016-02-03 |
 SMARTHEART 86263520 not registered Dead/Abandoned |
Shaklee Corporation 2014-04-25 |
 SMARTHEART 77930173 not registered Dead/Abandoned |
Normerica Inc. 2010-02-08 |
 SMARTHEART 77362600 not registered Dead/Abandoned |
DROLSHAGEN, BRIDGET M. 2008-01-02 |
 SMARTHEART 74526162 1990670 Dead/Cancelled |
HARLEY STREET SOFTWARE LTD. 1994-05-18 |
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