NA

Basic Information

• Brand Name: NA
• Primary DI: 00085412010717
• Version / Model: 4B7871
• Catalog Number: 4B7871
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 63ba01ef-2f17-4ad5-ae05-bdbb6204a236

Device Description

1.6% Sodium Chloride Processing Solution, 2000 mL

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSW	SYSTEM, PROCESSING FOR FROZEN BLOOD	Hematology	864.9145	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45519	Blood cell freeze/thaw system	An assembly of devices designed for the automated processing of red blood cells received indirectly from a donor so that the cells can be safely frozen for storage in a closed, disposable set, and when needed, thawed for use. The assembly will typically add an appropriate substance (e.g., glycerol) to the blood cells to allow freezing, and facilitate the thawing process. The assembly may also wash the red blood cells to remove glycerol and plasma and extracellular components; it may also resuspend the cells in an additive solution. It will typically be comprised of pumps, a centrifuge, air detectors, a dedicated shaker, monitoring devices, disposable set, and possibly print-out facilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412010712	GS1	CASE	6	In Commercial Distribution
Primary	00085412010717	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Recommended Strorage - Room Temperature
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid excessive heat.
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from freezing.
• Type: Storage Environment Temperature
• Temperature Range: Low: 25 Degrees Celsius