Thermo Scientific Pacific Hemostasis®

GUDID 00845275000818

Fisher Diagnostics

Multiple coagulation factor IVD, control

• Primary Device ID: 00845275000818
• NIH Device Record Key: 78d3c38c-11d6-4635-b228-21c5dd706972
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific Pacific Hemostasis®
• Version Model Number: 100560
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845275000818 [Primary]
GS1	00845275005653 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010750

FDA Product Code

• GGN: Plasma, Coagulation Control

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