primePICC

GUDID 20813623010165

3F x 45cm Single Lumen CT PICC Nursing Kit

PFM MEDICAL INCORPORATED

Peripherally-inserted central venous catheter
Primary Device ID20813623010165
NIH Device Record Keyc0c3be3f-8d08-43a8-be5b-f0c4a344f30a
Commercial Distribution StatusIn Commercial Distribution
Brand NameprimePICC
Version Model NumberPFM2CT3SP
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 Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813623010161 [Primary]
GS110813623010168 [Package]
Contains: 00813623010161
Package: Inner Pack [5 Units]
In Commercial Distribution
GS120813623010165 [Package]
Contains: 10813623010168
Package: Case [4 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-08
Device Publish Date2019-07-31

On-Brand Devices [primePICC]

208136230138216F (2.00mm) x 60cm TRIPLE LUMEN CT PICC OTW KIT
208136230137915F (1.67mm) x 55cm TRIPLE LUMEN CT PICC OTW KIT
208136230137606F (2.00mm) x 60cm DUAL LUMEN CT PICC OTW KIT
208136230137395F (1.67mm) x 55cm DUAL LUMEN CT PICC OTW KIT
208136230137085F (1.67mm) x 55cm SINGLE LUMEN CT OTW WIRE KIT
208136230136474F (1.33mm) x 50cm SINGLE LUMEN CT PICC OTW KIT
208136230136163F (1.00mm) x 45cm SINGLE LUMEN CT PICC OTW KIT
208136230101894F x 50cm Dual Lumen CT PICC Nursing Kit
208136230101724F x 50cm Single Lumen CT PICC Nursing Kit
208136230101653F x 45cm Single Lumen CT PICC Nursing Kit

Trademark Results [primePICC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRIMEPICC
PRIMEPICC
87104568 5178368 Live/Registered
PFM Medical, Inc.
2016-07-14

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