EXCOR® VAD
GUDID 04260090041055
Tank unit
Berlin Heart GmbH
External ventricular circulatory assist system| Primary Device ID | 04260090041055 |
| NIH Device Record Key | 2115dbdf-d4ea-4fea-88ef-18593491e5ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXCOR® VAD |
| Version Model Number | 1600190 |
| Company DUNS | 328654384 |
| Company Name | Berlin Heart GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com | |
| Phone | 1.281.863.9700 |
| info@berlinheartinc.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 78 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260090041055 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- H100004
FDA Product Code
| DSQ | Ventricular (Assisst) Bypass |
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 | 2014-09-24 |
On-Brand Devices [EXCOR® VAD]
| 04260090041086 | Manual pump |
| 04260090041055 | Tank unit |
| 04260090040409 | Arterial cannula for infans |
| 04260090041369 | Arterial cannula for infants |
| 04260090041352 | Arterial cannula for small children |
| 04260090041338 | Arterial cannula for children |
| 04260090041321 | Arterial cannula |
| 04260090041307 | Atrial cannula |
| 04260090041291 | Atrial cannula |
| 04260090041284 | Atrial Cannula |
| 04260090041277 | Atrial cannula for small children |
| 04260090040607 | Connecting set for cannulas |
| 04260090040591 | Connecting set for cannulas |
| 04260090040577 | Driving tube, blue |
| 04260090040560 | Driving tube, red |
| 04260090040553 | Accessory set PU valves |
| 04260090040539 | Apex cannula for infants |
| 04260090040515 | Apex cannula for small children |
| 04260090040508 | Arterial Cannula |
| 04260090040492 | Apex cannula for children |
| 04260090040461 | Atrial cannula for small children |
| 04260090040430 | Atrial cannula for children |
| 04260090040423 | Atrial cannula for children |
| 04260090040393 | Arterial cannula for small children |
| 04260090040386 | Arterial cannula for children |
| 04260090040379 | Atrial cannula for infants |
| 04260090040348 | Arterial cannula for children |
| 04260090040331 | Arterial cannula for children |
| 04260090040287 | Apex cannula one-part |
| 04260090040256 | Atrial cannula |
| 04260090040249 | Cannula extension set |
| 04260090040232 | Atrial cannula |
| 04260090040225 | Stationary Driving Unit Ikus Rev. 2.1 |
| 04260090040188 | Arterial cannula |
| 04260090040171 | Cannula extension set |
| 04260090040164 | Arterial cannula |
| 04260090040157 | Blood pump PU valves; 15ml |
| 04260090040140 | Cannula extension set |
| 04260090040126 | Blood pump PU valves; 30ml |
| 04260090040119 | Blood pump PU valves; 25ml |
| 04260090040102 | Blood pump PU valves; 10ml |
| 04260090040027 | Blood pump PU valves; 60ml |
| 04260090040010 | Blood pump PU valves; 50ml |
Trademark Results [EXCOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXCOR 87473184 5390200 Live/Registered |
NORTHERN TECHNOLOGIES INTERNATIONAL CORPORATION 2017-06-02 |
 EXCOR 78159509 2740522 Live/Registered |
Berlin Heart GmbH 2002-08-30 |
 EXCOR 76249847 2828914 Dead/Cancelled |
BERLIN HEART AG 2001-05-02 |
 EXCOR 76161290 3015836 Live/Registered |
NORTHERN TECHNOLOGIES INTERNATIONAL CORPORATION 2000-11-07 |
 EXCOR 74470776 1865664 Dead/Cancelled |
METHODE ELECTRONICS, INC. 1993-12-17 |
 EXCOR 74218533 not registered Dead/Abandoned |
ROGERS CORPORATION 1991-11-04 |
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