FDA.reportPublic FDA data

Pioneer IVF®

Primary DI
00815965021652
Brand
Pioneer IVF®
Company
LIFEGLOBAL GROUP, LLC
Model
GPPD-115
Catalog number
GPPD-115
Device description
Propump Dual 115V
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHKCURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHKCurette, Suction, Endometrial (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914241000PIONEER PRO-PUMP DUAL CONTROLPioneer Medical, Inc.1992-03-04HHK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815965021652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815965021652008159650216528159650216520815965021652

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, line-poweredAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure0.5 KiloPascal1.06 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)720-6375Sales@LifeGlobal.com

Regulatory Flags#

DUNS number
141732011
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815965020358LifeGlobal® MediaLGPS-005LGPS-0052016-09-21
00815965020693LifeGlobal® MediaGHSA-005GHSA-0052016-09-21
00815965020754LifeGlobal® MediaLPVP-002LPVP-0022016-09-21
00815965020938Coda®CIPR-001CIPR-0012016-09-21
00815965020945Coda®CXBL-001CXBL-0012016-09-21
00815965020952Coda®CXGR-001CXGR-0012016-09-21
00815965020976Coda®GCIF-001GCIF-0012016-09-21
00815965021195Coda®GCAF-001GCAF-0012016-09-21
00815965021331LifeGlobal® MicropipetMPAH-30*01*MPAH-30*01*2016-09-21
00815965021348Coda®GCAF-701GCAF-7012016-09-21
00815965021355Coda®CAFK-901CAFK-9012016-09-21
00815965021867LifeGlobal® MicropipetMPBL-35B*01*MPBL-35B*01*2016-09-23
00815965021874LifeGlobal® MicropipetMPBL-25F-30*01*MPBL-25F-30*01*2016-09-23
00815965021881LifeGlobal® MicropipetMPBL-35F-30*01*MPBL-35F-30*01*2016-09-23
00815965021898LifeGlobal® MicropipetMPBL-35F-35*01*MPBL-35F-35*01*2016-09-23
00815965021904LifeGlobal® MicropipetMPHL-35*01*MPHL-35*01*2016-09-23
00815965021911LifeGlobal® MicropipetMPHL-30*01*MPHL-30*01*2016-09-23
00815965021928LifeGlobal® MicropipetMPIC-35*01*MPIC-35*01*2016-09-23
00815965021935LifeGlobal® MicropipetMPIC-30*01*MPIC-30*01*2016-09-23
00815965021942LifeGlobal® MicropipetMPIC-30L*01*MPIC-30L*01*2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011927662Monarch Medical ProductsBioteque Taiwan Ltd.HHK2026-07-24
04719894436487LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436494LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
04719894436500LTL MedicalBioteque Taiwan Ltd.HHK2026-07-24
06974500612718Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612725Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612732Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612749Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612756Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612763Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612770Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612787Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612794Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612824Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612831Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612848Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612855Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612862Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612879Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612886Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612893Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612909Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613333Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613340Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613357Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613364Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613371Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
00810142352338Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
00810142352369Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
04719894432335BiotequeBioteque Taiwan Ltd.HHK2024-12-06