BBraun ASEPT 622281

GUDID 10813623011219

ASEPT 2,000mL Drainage Bag with Procedure Pack

PFM MEDICAL INCORPORATED

Closed-wound/centesis drainage receptacle
Primary Device ID10813623011219
NIH Device Record Keyd0567e51-f7e1-4338-b11e-290a86da641b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBBraun ASEPT
Version Model Number622281
Catalog Number622281
Company DUNS097736867
Company NamePFM MEDICAL INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does n
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
Emailcustomerservice@pfmmedicalusa.
Phone7607588749
Emailcustomerservice@pfmmedicalusa.

Device Identifiers

Device Issuing AgencyDevice ID
GS100813623011212 [Primary]
GS110813623011219 [Package]
Contains: 00813623011212
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCXApparatus, Suction, Ward Use, Portable, Ac-Powered

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 Date2016-09-29

On-Brand Devices [BBraun ASEPT]

10813623011257ASEPT 600mL Bare Evacuated Drainage Bottle
10813623011240ASEPT 1,000mL Bare Evacuated Drainage Bottle
10813623011219ASEPT 2,000mL Drainage Bag with Procedure Pack
10813623011202ASEPT 2,000mL Drainage Bag
10813623011196ASEPT 1,000mL Evacuated Drainage Bottle without Drain Line
10813623011189ASEPT 600mL Evacuated Drainage Bottle without Drain Line

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