Platelet Wash and Storage Solution

Basic Information

• Brand Name: Platelet Wash and Storage Solution
• Primary DI: 10888234000488
• Version / Model: 0005035
• Catalog Number: 0005035
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 18845d09-6007-4991-8b81-779a6516a34b

Device Description

Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47125	Platelet storage solution	A fluid used to partially replace plasma in the preparation and storage of buffy coat-derived platelet concentrates or apheresis platelet units. It typically includes several compounds [e.g., sodium chloride (NaCl), sodium citrate (Na3-citrate), potassium chloride (KCl), magnesium chloride (MgCl2)] to maintain optimal pH and minimize platelet aggregation at room temperature. It is supplied in a container (e.g., a polypropylene bag) and is not for direct intravenous (IV) infusion. This is single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234000488	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK880015	0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 10 Degrees Celsius