PR-84216

GUDID 20850005864244

16g x 1 1/4” IV CATHETER PURSAFETY R

PATHEN MEDICAL LLC

Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter Peripheral vascular/subcutaneous catheter
Primary Device ID20850005864244
NIH Device Record Keye40548c6-991b-4918-b3ec-da989ded5df0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePR-84216
Version Model NumberPR-84216
Company DUNS042928915
Company NamePATHEN MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com
Phone8773185421
Emailquestions@pathen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005864240 [Primary]
GS110850005864247 [Package]
Contains: 00850005864240
Package: [50 Units]
In Commercial Distribution
GS120850005864244 [Package]
Contains: 10850005864247
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter, Intravascular, Therapeutic, Short-Term Less 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 Date2019-05-02
Device Publish Date2019-04-24

Devices Manufactured by PATHEN MEDICAL LLC

20850005864640 - PS-843202019-11-18 20G X 1.88" IV CATHETER PURSAFETY S
20850005864619 - PS-8432422019-11-13 24GX .56" IV CATHETER PURSAFETY S
20850005864626 - PS-843262019-11-13 26GX 56" IV CATHETER PURSAFETY S
20850005864633 - PS-8432622019-11-13 26GX.75" IV CATHETER PURSAFETY S
00850005864561 - BASNWS -30/1502019-09-24 Administration Set, NO Spike, 150 Micron Filter, 30cc Syringe
10850005864605 - BMS-2135.17S2019-09-17 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock,
10850005864575 - BM-2135.172019-09-13 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock
10850005864582 - 0022312019-09-13 Extension Set, 6" w/ 3-way stopcock
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