PMI

Basic Information

• Brand Name: PMI
• Primary DI: 00812608021987
• Version / Model: PMIX02
• Catalog Number: PMIX02
• Company Name: PROGRESSIVE MEDICAL, INC.
• Labeler DUNS: 192135242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-18
• Public Version: 1
• Public Version Date: 2019-03-26
• Public Version Status: New
• Public Device Record Key: e5e63e7f-d6a5-4145-9016-ca37aace9e99

Device Description

Bifurcated Pharmacy Fluid Transfer Set with Universal Spike, Silicone Pump Insert with Bridge, Male Luer

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

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	00812608022038	GS1	Case	5	In Commercial Distribution
Package	00812608021994	GS1	Box	10	In Commercial Distribution
Primary	00812608021987	GS1

Customer Contacts

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