PFM PICC CT II PFM2CT6DN

GUDID 20813623017454

6F (2.00mm) x 60cm DUAL LUMEN CT PICC NURSING KIT

PFM MEDICAL INCORPORATED

Peripherally-inserted central venous catheter
Primary Device ID20813623017454
NIH Device Record Key4f04f6bc-25ec-4630-8a03-f06a5a9dcfbc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFM PICC CT II
Version Model NumberPFM2CT6DN
Catalog NumberPFM2CT6DN
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7607588749
Emailcustomerservice@pfmmedicalusa.
Phone7607588749
Emailcustomerservice@pfmmedicalusa.

Device Identifiers

Device Issuing AgencyDevice ID
GS100813623017450 [Primary]
GS110813623017457 [Package]
Contains: 00813623017450
Package: [5 Units]
In Commercial Distribution
GS120813623017454 [Package]
Contains: 10813623017457
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJSCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

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 Date2015-10-09

On-Brand Devices [PFM PICC CT II]

208136230406124F (1.33mm) x 50cm DUAL LUMEN CT PICC
208136230188025F (1.67mm) x 55cm DUAL LUMEN CT PICC NURSING KIT
208136230185816F (2.00mm) x 60cm DUAL LUMEN CT PICC
208136230185745F (1.67mm) x 55cm SINGLE LUMEN CT PICC LONG WIRE KIT
208136230185434F (1.33mm) x 50cm SINGLE LUMEN CT PICC LONG WIRE KIT
208136230185365F (1.67mm) x 55cm DUAL LUMEN CT PICC LONG WIRE KIT
208136230185294F (1.33mm) x 50cm SINGLE LUMEN CT PICC
208136230185125F (1.67mm) x 55cm DUAL LUMEN CT PICC
208136230185055F (1.67mm) x 55cm SINGLE LUMEN CT PICC
208136230180555F (1.67mm) x 55cm SINGLE LUMEN CT PICC NURSING KIT
208136230180484F (1.33mm) x 50cm SINGLE LUMEN CT PICC NURSING KIT
208136230174924F (1.33mm) x 50cm DUAL LUMEN CT PICC LONG WIRE KIT
208136230174854F (1.33mm) x 50cm DUAL LUMEN CT PICC NURSING KIT
208136230174783F (1.00mm) x 45cm SINGLE LUMEN CT PICC LONG WIRE KIT
208136230174613F (1.00mm) x 45cm SINGLE LUMEN CT PICC NURSING KIT
208136230174546F (2.00mm) x 60cm DUAL LUMEN CT PICC NURSING KIT
208136230174306F (2.00mm) x 60cm DUAL LUMEN CT PICC LONG WIRE KIT

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