TandemLung
GUDID 00814112020425
TandemHeart blood pump kit with 29 Fr V-V cannula, TandemLung oxygenator, and accessories
CARDIACASSIST, INC.
Mobile extracorporeal gas exchange system catheter kit| Primary Device ID | 00814112020425 |
| NIH Device Record Key | b4005930-3764-4021-87b5-69671568bed5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TandemLung |
| Version Model Number | 5730-2916 |
| Company DUNS | 948683941 |
| Company Name | CARDIACASSIST, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814112020425 [Primary] |
FDA Product Code
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2016-07-06 |
On-Brand Devices [TandemLung]
| 00814112020432 | TandemHeart blood pump kit with 31 Fr V-V cannula, TandemLung oxygenator, and accessories |
| 00814112020425 | TandemHeart blood pump kit with 29 Fr V-V cannula, TandemLung oxygenator, and accessories |
| 00814112020241 | TandemLung Oxygenator Kit with accessories |
Trademark Results [TandemLung]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TANDEMLUNG 86346986 5050270 Live/Registered |
CardiacAssist, Inc. 2014-07-24 |
 TANDEMLUNG 85965234 not registered Dead/Abandoned |
CardiacAssist, Inc. 2013-06-20 |
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