ASEPT Pleural Drainage System M7001

GUDID 10813623017013

ASEPT Pleural Drainage System

PFM MEDICAL INCORPORATED

Pleural/peritoneal drainage catheterization kit
Primary Device ID10813623017013
NIH Device Record Key48ca3f29-2643-43d7-8aff-d12c2c857831
Commercial Distribution StatusIn Commercial Distribution
Brand NameASEPT Pleural Drainage System
Version Model NumberM7001
Catalog NumberM7001
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 Kittrue
Device Combination Producttrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813623017016 [Primary]
GS110813623017013 [Package]
Contains: 00813623017016
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2019-09-06
Device Publish Date2016-10-02

On-Brand Devices [ASEPT Pleural Drainage System]

10813623017013ASEPT Pleural Drainage System
10813623011356ASEPT Pleural Drainage System
10813623011165ASEPT Pleural Drainage System

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