Synergy XS

GUDID 20876604001231

4Fr x 60cm Double Lumen Synergy XS CT PICC Basic Kit for US

Health Line International Corporation

Peripherally-inserted central venous catheter
Primary Device ID20876604001231
NIH Device Record Key870f3b02-10de-4583-ad65-db687dfd5db2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynergy XS
Version Model NumberA14-04260-US
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
GS100876604001237 [Primary]
GS110876604001234 [Package]
Contains: 00876604001237
Package: Inner [5 Units]
In Commercial Distribution
GS120876604001231 [Package]
Contains: 10876604001234
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 Date2016-11-17

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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