| Primary Device ID | 00733132636525 |
| NIH Device Record Key | 23dd70cf-f7c0-46b1-a59b-e8f9821d221a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GORE CARDIOFORM ASD Occluder |
| Version Model Number | ASD48A |
| Catalog Number | ASD48A |
| Company DUNS | 967358115 |
| Company Name | W. L. Gore & Associates, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Outer Diameter | 48 Millimeter |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00733132636525 [Primary] |
| MLV | Transcatheter Septal Occluder |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-15 |
| Device Publish Date | 2019-08-07 |
| 00733132636518 | GORE CARDIOFORM ASD Occluder 44 mm 10Fr |
| 00733132636501 | GORE CARDIOFORM ASD Occluder 37 mm 10Fr |
| 00733132636495 | GORE CARDIOFORM ASD Occluder 32 mm 10Fr |
| 00733132636488 | GORE CARDIOFORM ASD Occluder 27 mm 10Fr |
| 00733132636525 | GORE CARDIOFORM ASD Occluder 48mm 14Fr |