PERFADEX® Plus 19950
GUDID 07350069520296
Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flushing, cold static storag
Xvivo Perfusion AB
Donor-organ preservation solution| Primary Device ID | 07350069520296 |
| NIH Device Record Key | e74ed705-3c03-496e-a9c0-75849c6f0b68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERFADEX® Plus |
| Version Model Number | 19950 |
| Catalog Number | 19950 |
| Company DUNS | 559895730 |
| Company Name | Xvivo Perfusion AB |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350069520296 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170826
FDA Product Code
| KDN | System, Perfusion, Kidney |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-19 |
Devices Manufactured by Xvivo Perfusion AB
| 07350069520401 - XVIVO Disposable Lung Kit | 2023-10-09 The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used wit |
| 07350069520425 - XVIVO Click Adapter | 2021-11-08 Intended as an adapter between the Perfadex® Plus bag and a tubing set with a standard spike. |
| 07350069520500 - XVIVO Lung Cannula Set II™ | 2021-10-11 XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorpore |
| 07350069520234 - PERFADEX Plus® | 2019-12-12 Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flush |
| 07350069520241 - PERFADEX Plus® | 2019-12-12 Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is intended for the flush |
| 07350069520289 - PERFADEX Plus (Click US) | 2019-12-12 PERFADEX Plus is a pre-buffered, extracellular solution of dextran 40 containing calcium. The device is indicated for the flushi |
| 07350069520050 - Perfadex with THAM | 2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal |
| 07350069520067 - Perfadex with THAM | 2019-12-05 Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal |
Trademark Results [PERFADEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERFADEX 75374486 2420380 Live/Registered |
XVIVO PERFUSION AB 1997-10-10 |
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