Pioneer IVF®

Basic Information

• Brand Name: Pioneer IVF®
• Primary DI: 00815965021683
• Version / Model: GPPS-230
• Catalog Number: GPPS-230
• Company Name: LIFEGLOBAL GROUP, LLC
• Labeler DUNS: 141732011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 71d95ae2-a992-4135-8f87-47a551f81cba

Device Description

Propump Single 230V

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHK	CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)	Obstetrics/Gynecology	884.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36777	General-purpose suction system, line-powered	An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815965021683	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K914220	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .5 – 1.06 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity