Thermo Scientific Pacific Hemostasis®

Basic Information

• Brand Name: Thermo Scientific Pacific Hemostasis®
• Primary DI: 00845275000757
• Version / Model: 100258
• Company Name: Fisher Diagnostics
• Labeler DUNS: 183998769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 79552fa9-d463-4cdf-b468-715261665c80

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GHM	Test, Sickle Cell	Hematology	864.7825	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55904	Haemoglobin S (HbS) IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen using an electrophoresis method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845275000757	GS1
Unit of Use	00845275005516	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K854079	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius