ASEPT Peritoneal Drainage System M7000

GUDID 10813623015378

ASEPT 1,000mL Drainage Kit

PFM MEDICAL INCORPORATED

Pleural/peritoneal drainage catheterization kit
Primary Device ID10813623015378
NIH Device Record Keyceab0a96-f227-45f0-8ab3-9cc33c7c0351
Commercial Distribution StatusIn Commercial Distribution
Brand NameASEPT Peritoneal Drainage System
Version Model NumberM7000
Catalog NumberM7000
Company DUNS097736867
Company NamePFM MEDICAL INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
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
GS100813623015371 [Primary]
GS110813623015378 [Package]
Contains: 00813623015371
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDQBottle, Collection, Vacuum

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-09-06
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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