Pioneer IVF® GPPD-115

GUDID 00815965021652

Propump Dual 115V

LIFEGLOBAL GROUP, LLC

General-purpose suction system, line-powered
Primary Device ID00815965021652
NIH Device Record Key56858676-12ef-40aa-8f5c-8ed79e898bba
Commercial Distribution StatusIn Commercial Distribution
Brand NamePioneer IVF®
Version Model NumberGPPD-115
Catalog NumberGPPD-115
Company DUNS141732011
Company NameLIFEGLOBAL GROUP, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)720-6375
EmailSales@LifeGlobal.com
Phone+1(800)720-6375
EmailSales@LifeGlobal.com
Phone+1(800)720-6375
EmailSales@LifeGlobal.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal
Storage Environment Atmospheric PressureBetween 0.5 KiloPascal and 1.06 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100815965021652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHKCURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [Pioneer IVF®]

00815965021683Propump Single 230V
00815965021676Propump Single 115V
00815965021669Propump Dual 230V
00815965021652Propump Dual 115V

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