PMI

Basic Information

• Brand Name: PMI
• Primary DI: 00812608021529
• Version / Model: PMIORCAP20
• Catalog Number: PMIORCAP20
• Company Name: PROGRESSIVE MEDICAL, INC.
• Labeler DUNS: 192135242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-01
• Public Version: 5
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: 68a821eb-8ea6-4a36-a66f-ef9830b37af9

Device Description

PMI Cholangiogram Combo Pack Includes: Disposable Operative Cholangiogram Catheter 20" and (PMIPIN15) Disposable Percutaneous Introducer 4" length and 14 guage

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
GBZ	Catheter, Cholangiography	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60437	Interventional radiology percutaneous-access kit, single-use	A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00812608021536	GS1	Box	10	In Commercial Distribution
Primary	00812608021529	GS1

Customer Contacts

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