| Primary Device ID | M7298001012XL2 |
| NIH Device Record Key | 1fc1d316-5093-4b87-ae5c-76929286ea11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardiva VASCADE MVP XL VVCS 10-12F |
| Version Model Number | 800-1012XL |
| Company DUNS | 128112195 |
| Company Name | CARDIVA MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com | |
| Phone | +1-800-537-2802 |
| customerserviceNA@haemonetics.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7298001012XL0 [Primary] |
| HIBCC | M7298001012XL1 [Package] Contains: M7298001012XL0 Package: 5-pk [5 Units] In Commercial Distribution |
| HIBCC | M7298001012XL2 [Package] Contains: M7298001012XL0 Package: 10-pk [10 Units] In Commercial Distribution |
| HIBCC | M7298001012XL3 [Package] Contains: M7298001012XL0 Package: 1-pk [1 Units] In Commercial Distribution |
| MGB | Device, Hemostasis, Vascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-06 |
| Device Publish Date | 2024-05-29 |
| M7298001012XL2 - Cardiva VASCADE MVP XL VVCS 10-12F | 2024-06-06The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. |
| M7298001012XL2 - Cardiva VASCADE MVP XL VVCS 10-12F | 2024-06-06 The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access |
| M729700500DX1 - Cardiva VASCADE 5F VCS | 2021-02-05 The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system |
| M729700580I1 - Cardiva VASCADE 6/7F VCS | 2021-02-05 The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system |
| M729800612C2 - Cardiva VASCADE MVP VVCS 6-12F | 2021-02-05 The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal the femoral venous access site at the completion of ca |