Synergy XS

GUDID 20876604000913

4Fr x 60cm Dual Lumen Synergy-XS CT PICC IR Kit

Health Line International Corporation

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter
Primary Device ID20876604000913
NIH Device Record Key2de75b2f-b46a-4171-8f84-e516000ec38f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergy XS
Version Model NumberA14-04260-IR
Company DUNS806251398
Company NameHealth Line International Corporation
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100876604000919 [Primary]
GS110876604000916 [Package]
Contains: 00876604000919
Package: Inner [5 Units]
In Commercial Distribution
GS120876604000913 [Package]
Contains: 10876604000916
Package: Carton [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-21
Device Publish Date2016-11-21

On-Brand Devices [Synergy XS]

208766040012483Fr x 60cm Single Lumen Synergy XS CT PICC IR Kit for US
208766040012314Fr x 60cm Double Lumen Synergy XS CT PICC Basic Kit for US
208766040012243Fr x 60cm Single Lumen Synergy XS CT PICC Basic Kit for US
208766040009134Fr x 60cm Dual Lumen Synergy-XS CT PICC IR Kit
008766040006744Fr x 60 cm Dual Lumen Synergy XS CT PICC Nursing Kit
008766040006293Fr x 60cm Single Lumen Synergy XS CT PICC Nursing Kit
108766040008793Fr x 60cm Single Lumen Synergy XS CT PICC IR Kit
108766040002823Fr x 60cm Single Lumen Synergy XS CT PICC Basic Kit

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