Orion II

GUDID 20876604001583

16Ga x 20 cm Single Lumen Orion II CT CVC Kit

Health Line International Corporation

Central venous catheterization kit, short-term
Primary Device ID20876604001583
NIH Device Record Key6dcf7e8c-9b80-42a2-9587-3903f365200e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrion II
Version Model NumberA33-05120
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
GS100876604001589 [Primary]
GS110876604001586 [Package]
Contains: 00876604001589
Package: Inner Pack [5 Units]
In Commercial Distribution
GS120876604001583 [Package]
Contains: 10876604001586
Package: Case [4 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-24
Device Publish Date2018-01-30

On-Brand Devices [Orion II]

208766040022767Fr x 30 cm Dual Lumen Orion II CT CVC Kit
208766040022527Fr x 25 cm Dual Lumen Orion II CT CVC Kit
208766040022387Fr x 24 cm Dual Lumen Orion II CT CVC Kit
2087660400201616Ga x 30 cm Single Lumen Orion II CT CVC Kit
2087660400199616Ga x 24 cm Single Lumen Orion II CT CVC Kit
208766040017297Fr x 16 cm Dual Lumen Orion II CT CVC Kit
208766040016997Fr x 13 cm Dual Lumen Orion II CT CVC Kit
2087660400158316Ga x 20 cm Single Lumen Orion II CT CVC Kit
2087660400157616Ga x 16 cm Single Lumen Orion II CT CVC Kit
2087660400156916Ga x 15 cm Single Lumen Orion II CT CVC Kit
208766040014087Fr x 20 cm Triple Lumen Orion II CT CVC Kit
208766040013927Fr x 15 cm Triple Lumen Orion II CT CVC Kit
208766040013857Fr x 20 cm Dual Lumen Orion II CT CVC Kit
2087660400135416Ga x 13 cm Single Lumen Orion II CT CVC Kit
2087660400134716 Ga x 10 cm Single Lumen Orion II CT CVC Kit
208766040013307Fr x 15 cm Dual Lumen Orion II CT CVC Kit

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