VYAFUSER™ 2089870410
GUDID 05713495001043
The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV
Phillips-Medisize A/S
Ambulatory syringe pump| Primary Device ID | 05713495001043 |
| NIH Device Record Key | 22843d91-a8a9-4ad8-ac07-7ae0cd9cff45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VYAFUSER™ |
| Version Model Number | VYAFUSER PUMP KIT US/PR A |
| Catalog Number | 2089870410 |
| Company DUNS | 306047440 |
| Company Name | Phillips-Medisize A/S |
| 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 | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | (866) 489-2538 |
| GPODuopa@abbvie.com | |
| Phone | (866) 489-2538 |
| GPODuopa@abbvie.com | |
| Phone | (866) 489-2538 |
| GPODuopa@abbvie.com | |
| Phone | (866) 489-2538 |
| GPODuopa@abbvie.com | |
| Phone | (866) 489-2538 |
| GPODuopa@abbvie.com | |
| Phone | (866) 489-2538 |
| GPODuopa@abbvie.com | |
| Phone | (866) 489-2538 |
| GPODuopa@abbvie.com |
Device Dimensions
| Length | 6.7 Inch |
| Width | 3 Inch |
| Depth | 1.3 Inch |
| Weight | 285 Gram |
| Length | 6.7 Inch |
| Width | 3 Inch |
| Depth | 1.3 Inch |
| Weight | 285 Gram |
| Length | 6.7 Inch |
| Width | 3 Inch |
| Depth | 1.3 Inch |
| Weight | 285 Gram |
| Length | 6.7 Inch |
| Width | 3 Inch |
| Depth | 1.3 Inch |
| Weight | 285 Gram |
| Length | 6.7 Inch |
| Width | 3 Inch |
| Depth | 1.3 Inch |
| Weight | 285 Gram |
| Length | 6.7 Inch |
| Width | 3 Inch |
| Depth | 1.3 Inch |
| Weight | 285 Gram |
| Length | 6.7 Inch |
| Width | 3 Inch |
| Depth | 1.3 Inch |
| Weight | 285 Gram |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 53.3 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 53.3 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 53.3 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 53.3 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 53.3 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 53.3 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 53.3 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713495000152 [Primary] |
| GS1 | 05713495000169 [Package] Contains: 05713495000152 Package: Multi Shipper Box [4 Units] In Commercial Distribution |
| GS1 | 05713495001043 [Direct Marking] |
FDA Product Code
| FRN | Pump, Infusion |
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 | 2024-11-21 |
| Device Publish Date | 2024-11-13 |
Devices Manufactured by Phillips-Medisize A/S
| 05713495001043 - VYAFUSER™ | 2024-11-21The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV |
| 05713495001043 - VYAFUSER™ | 2024-11-21 The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV |
| 05713495000084 - Skytrofa Auto-Injector | 2021-11-01 |
| 05713495000015 - BETACONNECT | 2021-10-15 |
| 05713495000039 - myBETAapp | 2021-10-15 |
| 05713495000046 - myBETAapp | 2021-10-15 |
| 05713495000053 - myBETAapp | 2021-10-15 |
| 05713495000060 - myBETAapp | 2021-10-15 |
Trademark Results [VYAFUSER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VYAFUSER 98627518 not registered Live/Pending |
AbbVie AB 2024-07-01 |
 VYAFUSER 90543444 not registered Live/Pending |
AbbVie AB 2021-02-24 |
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