Floseal 1505288
GUDID 50085412532733
FLOSEAL Hemostatic Matrix, 5 mL
BAXTER HEALTHCARE CORPORATION
Collagen haemostatic agent| Primary Device ID | 50085412532733 |
| NIH Device Record Key | 68f7bd7e-61ca-4169-9157-ca4e57eeef06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Floseal |
| Version Model Number | 1505288 |
| Catalog Number | 1505288 |
| Company DUNS | 628013963 |
| Company Name | BAXTER HEALTHCARE CORPORATION |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze. |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412532738 [Primary] |
| GS1 | 50085412532733 [Package] Contains: 00085412532738 Package: CASE [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P990009
FDA Product Code
| PMX | Absorbable collagen hemostatic agent with thrombin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-04-12 |
On-Brand Devices [Floseal]
| 50085412532863 | FLOSEAL Hemostatic Matrix, 10 mL |
| 50085412532733 | FLOSEAL Hemostatic Matrix, 5 mL |
Trademark Results [Floseal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLOSEAL 75355764 2296613 Live/Registered |
Baxter International Inc. 1997-09-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.