| Primary Device ID | 05413765580970 |
| NIH Device Record Key | 9ac96d69-daca-4d03-9a51-69a58cdd34cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RECOTHROM SPRAY KIT |
| Version Model Number | ADS201802 |
| Catalog Number | ADS201802 |
| Company DUNS | 005083209 |
| Company Name | BAXTER HEALTHCARE CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com | |
| Phone | +1(866)888-2472 |
| medinfo_medproducts@baxter.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05413765580970 [Primary] |
| KYZ | SYRINGE, IRRIGATING (NON DENTAL) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-09 |
| Device Publish Date | 2025-12-01 |
| 05413765580970 - RECOTHROM SPRAY KIT | 2025-12-09RECOTHROM SPRAY APPLICATOR KIT includes several components designed for topical application of Recothrom onto the bleeding site to aid hemostasis. The spray kit components and packaging are to be used in a sterile environment. The Spray Kit has been designed to be compatible with Recothrom, Thrombin topical (Recombinant) used in the acute care settings of a hospital. |
| 05413765580970 - RECOTHROM SPRAY KIT | 2025-12-09 RECOTHROM SPRAY APPLICATOR KIT includes several components designed for topical application of Recothrom onto the bleeding site |
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