ASEPT M7005

GUDID 20813623017058

ASEPT Drainage Line Set

PFM MEDICAL INCORPORATED

Peritoneal drainage catheter
Primary Device ID20813623017058
NIH Device Record Key14ffc4fb-70f7-4151-80c7-592c550fcac0
Commercial Distribution StatusIn Commercial Distribution
Brand NameASEPT
Version Model NumberM7005
Catalog NumberM7005
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com
Phone7607588749
Emailregulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813623017054 [Primary]
GS110813623017051 [Package]
Contains: 00813623017054
Package: [10 Units]
In Commercial Distribution
GS120813623017058 [Package]
Contains: 10813623017051
Package: [10 Units]
In Commercial Distribution

FDA Product Code

DWMApparatus, Suction, Patient Care

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-06
Device Publish Date2019-03-31

On-Brand Devices [ASEPT]

10813623017020ASEPT 600mL Drainage Kit
10813623016986ASEPT 1,000mL Starter Kit
10813623016979ASEPT 600mL Starter Kit
10813623015743ASEPT 600mL Drainage Bottle with Y-Site Drain
00813623012066ASEPT 1000mL Drainage Bottle with Y-Site Drain
20813623011384ASEPT Procedure Pack
20813623017058ASEPT Drainage Line Set
20813623017041ASEPT Replacement Valve

Trademark Results [ASEPT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASEPT
ASEPT
88598012 not registered Live/Pending
PFM MEDICAL, INC.
2019-08-29
ASEPT
ASEPT
85138106 4015067 Live/Registered
PFM Medical, Inc.
2010-09-24
ASEPT
ASEPT
76186686 3310210 Live/Registered
ASEPT INTERNATIONAL AB
2000-12-22

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