| Primary Device ID | 55413760308376 | 
| NIH Device Record Key | 39074d91-7ab7-4f55-9420-fca8821f5556 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Fibrinotherm | 
| Version Model Number | 0600047 | 
| Catalog Number | 0600047 | 
| Company DUNS | 005146311 | 
| Company Name | BAXTER INTERNATIONAL INC. | 
| 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 | false | 
| 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 | false | 
| OTC Over-The-Counter | true | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05413760308371 [Primary] | 
| GS1 | 55413760308376 [Package] Contains: 05413760308371 Package: CASE [1 Units] In Commercial Distribution | 
| JRG | BLOCK, HEATING | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-12-13 | 
| Device Publish Date | 2018-09-21 | 
| 50085412676628 - CLR1 - CLEARLINK | 2023-07-24 Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 100” (2.5m) approx., 10 drops/mL | 
| 50085412002335 - INTERLINK | 2020-06-30 Extension Set, Injection Site, Male Luer Lock Adapter with Retractable Collar | 
| 50085412031199 - INTERLINK | 2020-06-30 Y-Type Blood/Solution Set, 40 and 150 Micron Dual Screen Filter, Injection Site, Male Luer Lock Adapter with Retractable Collar | 
| 50085412065293 - INTERLINK | 2020-06-30 Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter and Pressure Pump, Injection Site, Male Luer Lock Adapter wi | 
| 50085412046162 - NA | 2020-05-06 Evacuated Container, 1000 mL | 
| 50085412565625 - NA | 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar | 
| 50085412565946 - NA | 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar | 
| 50085412000522 - INTERLINK/CONTINU-FLO | 2019-12-11 Non-DEHP CONTINU-FLO Solution Set, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  FIBRINOTHERM  75028463  2124750 Live/Registered | BAXTER INTERNATIONAL INC. 1995-12-06 | 
|  FIBRINOTHERM  73721048  1528065 Dead/Cancelled | IMMUNO AKTIENGESELLSCHAFT FUR CHEMISCH-MEDIZINISCHE PRODUKTE 1988-04-07 |