PFM PICC CT II PFM2CT4SN

GUDID 20813623018048

4F (1.33mm) x 50cm SINGLE LUMEN CT PICC NURSING KIT

PFM MEDICAL INCORPORATED

Peripherally-inserted central venous catheter
Primary Device ID20813623018048
NIH Device Record Key7a495701-12e3-4bd1-a95d-61efd9cd3307
Commercial Distribution StatusIn Commercial Distribution
Brand NamePFM PICC CT II
Version Model NumberPFM2CT4SN
Catalog NumberPFM2CT4SN
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
GS100813623018044 [Primary]
GS110813623018041 [Package]
Contains: 00813623018044
Package: [5 Units]
In Commercial Distribution
GS120813623018048 [Package]
Contains: 10813623018041
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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