PME014NB

GUDID 10850005864452

14" Microbore extension set with pinch clamp male luer lock with non-bonded needle-free connector, PINCH CLAMP NON BONDED

PATHEN MEDICAL LLC

Intravenous administration tubing extension set
Primary Device ID10850005864452
NIH Device Record Key1ecb390c-975a-4d6a-a8d0-b58f73b5dda7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePME014NB
Version Model NumberPME014NB
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 Datetrue
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005864455 [Primary]
GS110850005864452 [Package]
Contains: 00850005864455
Package: [100 Units]
In Commercial Distribution
GS120850005864459 [Package]
Contains: 00850005864455
Package: [50 Units]
In Commercial Distribution

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-24
Device Publish Date2019-07-15

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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