PMI

Basic Information

• Brand Name: PMI
• Primary DI: 00812608020980
• Version / Model: PMIORCAP20
• Catalog Number: PMIORCAP20
• Company Name: PROGRESSIVE MEDICAL, INC.
• Labeler DUNS: 192135242
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 3
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: 2dd97b32-e2f3-4295-a6db-a0333985ae75
• Distribution End Date: 2017-08-01

Device Description

For Percutaneous Insertion, Combo Pack Includes:(PMIORCA20) Disposable Operative Cholangiogram Catheter 20" & (PIN-15) Disposable Percutaneous Introducer 4" length and 14 gauge

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: Yes
• 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
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	10812608020987	GS1	Box	10	Not in Commercial Distribution	2017-08-01
Primary	00812608020980	GS1

Customer Contacts

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