Infusion Set for Single Use

GUDID 06970440020163

Shinva Ande Healthcare Apparatus Co., Ltd

Infusion controller administration set
Primary Device ID06970440020163
NIH Device Record Key3abaccb1-d0c6-4a26-b43a-35e48d37b6d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfusion Set for Single Use
Version Model NumberAD0201
Company DUNS421062164
Company NameShinva Ande Healthcare Apparatus Co., Ltd
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970440020033 [Primary]
GS106970440020156 [Package]
Contains: 06970440020033
Package: [40 Units]
In Commercial Distribution
GS106970440020163 [Package]
Contains: 06970440020033
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[06970440020163]

Ethylene Oxide


[06970440020163]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-15

On-Brand Devices [Infusion Set for Single Use]

06970440020309AD0502
06970440020286AD0501
06970440020262AD0402
06970440020248AD0401
06970440020224AD0302
06970440020200AD0301
06970440020187AD0202
06970440020163AD0201
06970440020149AD0102
06970440020019AD0101

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