SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET

Basic Information

• Brand Name: SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET
• Primary DI: 00810080610583
• Version / Model: G82711-M
• Company Name: MPS Pharma & Medical, Inc.
• Labeler DUNS: 117970217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-24
• Public Version: 1
• Public Version Date: 2022-09-01
• Public Version Status: New
• Public Device Record Key: b9571fc5-7b49-4214-9414-4c0f0eab1d41

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: Yes
• 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
NEP	System/Device, Pharmacy Compounding	General Hospital	880.5440	2
JTB	Device, Media Dispensing/Stacking	Microbiology	866.2440	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41646	Compounding transfer set	A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810080610580	GS1	Case	10	In Commercial Distribution
Primary	00810080610583	GS1