Sampling Site Coupler

Basic Information

• Brand Name: Sampling Site Coupler
• Primary DI: 14086000903209
• Version / Model: 4C2405
• Catalog Number: 4C2405
• Company Name: Fresenius Kabi AG
• Labeler DUNS: 315654579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2022-06-03
• Public Version: 1
• Public Version Date: 2022-06-13
• Public Version Status: New
• Public Device Record Key: a324a25f-7abe-4337-9de2-454ff2af0ff0

Device Description

Sampling Site Coupler

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
44903	Blood transfer set	A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24086000903206	GS1	Carton	2	In Commercial Distribution
Primary	14086000903209	GS1
Unit of Use	04086000903202	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature. Protect from freezing. Avoid excessive heat.