Thermo Scientific Pacific Hemostasis®

GUDID 00845275000542

Fisher Diagnostics

Prothrombin time (PT) IVD, kit, clotting, rapid Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical Prothrombin time (PT) IVD, kit, rapid clotting, clinical

• Primary Device ID: 00845275000542
• NIH Device Record Key: 03cfa53a-8c61-4792-b5a5-512d6eb3c6bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific Pacific Hemostasis®
• Version Model Number: 100356
• Company DUNS: 183998769
• Company Name: Fisher Diagnostics
• Device Count: 10
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx
• Phone: 800-528-0494
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845275000542 [Primary]
GS1	00845275005608 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994100

FDA Product Code

• GJS: Test, Time, Prothrombin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Thermo Scientific Pacific Hemostasis®]

• 00845275000979: 102000
• 00845275000962: 101200
• 00845275000955: 101100
• 00845275000948: 101000
• 00845275000931: 100900
• 00845275000924: 100806
• 00845275000917: 100800
• 00845275000900: 100665
• 00845275000894: 100656
• 00845275000887: 100654
• 00845275000870: 100651
• 00845275000863: 100650
• 00845275000856: 100644
• 00845275000849: 100606
• 00845275000832: 100603
• 00845275000825: 100600
• 00845275000818: 100560
• 00845275000801: 100362
• 00845275000795: 100357
• 00845275000771: 100314
• 00845275000764: 100309
• 00845275000757: 100258
• 00845275000740: 100251
• 00845275000733: 100250
• 00845275000719: 100240
• 00845275000702: 100070
• 00845275000696: 100050
• 00845275000689: 100013
• 00845275000672: 100011
• 00845275000665: 100403
• 00845275000658: 100312
• 00845275000641: 100402
• 00845275000634: 100308
• 00845275000627: 100647
• 00845275000610: 100607
• 00845275000603: 100604
• 00845275000597: 100602
• 00845275000580: 100601
• 00845275000573: 100597
• 00845275000566: 100596
• 00845275000559: 100595
• 00845275000542: 100356
• 00845275000535: 100354
• 00845275000528: 100353
• 00845275000511: 100304
• 00845275000504: 100301