ASEPT Peritoneal Drainage System M7030

GUDID 20813623011117

ASEPT Vented Lock Cap

PFM MEDICAL INCORPORATED

Peritoneal drainage catheter
Primary Device ID20813623011117
NIH Device Record Keycfd8dfe2-7eff-4105-aff8-fa09e7cc03ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameASEPT Peritoneal Drainage System
Version Model NumberM7030
Catalog NumberM7030
Company DUNS097736867
Company NamePFM MEDICAL INCORPORATED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607588797
Emailcustomerservice@pfmmedicalusa.com
Phone7607588797
Emailcustomerservice@pfmmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813623011113 [Primary]
GS110813623011110 [Package]
Contains: 00813623011113
Package: [10 Units]
In Commercial Distribution
GS120813623011117 [Package]
Contains: 10813623011110
Package: [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJSCatheter, Peritoneal, Long-Term Indwelling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-15

On-Brand Devices [ASEPT Peritoneal Drainage System]

10813623019109ASEPT 2,000mL Drainage Bag
10813623017068ASEPT Peritoneal Drainage System
10813623015378ASEPT 1,000mL Drainage Kit
10813623014227ASEPT Drainage Bag with Procedure Pack
10813623011158ASEPT Peritoneal Drainage System
10813623011141ASEPT 1,000mL Drainage Kit
20813623011117ASEPT Vented Lock Cap

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