Lyophilized Platelets

Basic Information

• Brand Name: Lyophilized Platelets
• Primary DI: 05391521420091
• Version / Model: 50710
• Company Name: TCOAG IRELAND LIMITED
• Labeler DUNS: 985039126
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 6
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 54694612-fcb8-4a52-b7cd-daa107bf9466
• Distribution End Date: 2020-07-31

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	864.7290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56091	Platelet aggregation study IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents and a nephelometry/turbidimetry method. Platelet aggregation agents used may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391521420091	GS1

Premarket Submissions

Submission Number	Supplement Number
K920981	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius