| Primary Device ID | 50085412083327 |
| NIH Device Record Key | 88949064-0dcd-4932-a0db-18094932908e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coseal Surgical Sealant Replacement Applicator |
| Version Model Number | 934033 |
| Catalog Number | 934033 |
| 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 | 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 |
| Height | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Length | 7 Centimeter |
| Height | 7 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature (approximately 25 degrees celsius) |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412083322 [Primary] |
| GS1 | 50085412083327 [Package] Contains: 00085412083322 Package: CASE [5 Units] In Commercial Distribution |
| NBE | Sealant,Polymerizing |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-10-09 |
| 05413765851797 - Novum IQ | 2024-04-18 The Novum IQ Large Volume Pump (LVP) is a large volume infusion pump system that provides delivery of fluids into a patient in a |
| 51978860004350 - CLEARLINK/CONTINU-FLO | 2024-04-04 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 1 |
| 51978860004367 - CLEARLINK/CONTINU-FLO | 2024-04-04 QuickStay Set, 24 Hour Max Use, For Gravity Use Only, Clearlink System, Non-DEHP Continu-Flo Solution Set with Duo-Vent Spike, 9 |
| 05413765580895 - NOV - Novum IQ | 2023-11-30 Infusion Pump Management unit, mobile |
| 50085412676635 - DUO - DUO-VENT | 2023-07-19 Solution Set with DUO-VENT Spike |
| 05413765891335 - PerClot | 2023-07-03 PerClot 1g - 9cm Standard Tip |
| 05413765891366 - PerClot | 2023-07-03 PerClot 3g - 9cm Standard Tip |
| 05413765891373 - PerClot | 2023-07-03 PerClot 5g - 9cm Standard Tip |