Powerheart® MDLink 400621-046
GUDID 00812394021321
MDLink SW 10.16
CARDIAC SCIENCE CORPORATION
External defibrillator application software| Primary Device ID | 00812394021321 |
| NIH Device Record Key | 56bbc5dc-7414-47db-ac06-50113c92c0ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Powerheart® MDLink |
| Version Model Number | 400621-046 |
| Catalog Number | 400621-046 |
| Company DUNS | 080355564 |
| Company Name | CARDIAC SCIENCE CORPORATION |
| 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 | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812394020393 [Previous] |
| GS1 | 00812394021321 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102496
FDA Product Code
| MKJ | Automated External Defibrillators (Non-Wearable) |
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 | 2017-03-02 |
On-Brand Devices [Powerheart® MDLink]
| 00812394021321 | MDLink SW 10.16 |
| 00812394020393 | MDLink SW 10.15 |
Trademark Results [Powerheart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERHEART 78905168 3206323 Live/Registered |
CARDIAC SCIENCE CORPORATION 2006-06-09 |
 POWERHEART 77687247 not registered Dead/Abandoned |
Hunter Laboratories, Inc. 2009-03-10 |
 POWERHEART 74367566 1955504 Live/Registered |
CARDIAC SCIENCE CORPORATION 1993-03-12 |
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