NIPRO SOLUTION INFUSION SET

GUDID 10383790003367

NIPRO MEDICAL CORPORATION

Intravenous administration set Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive
Primary Device ID10383790003367
NIH Device Record Keyf1516b83-f6f5-4988-9bcf-19aac4d4ce00
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIPRO SOLUTION INFUSION SET
Version Model NumberIS-01-A/A-21G
Company DUNS797372554
Company NameNIPRO MEDICAL CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com
Phone+1(908) 393-7030
Emailinfo@nipromed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100383790003360 [Primary]
GS110383790003367 [Package]
Contains: 00383790003360
Package: [100 Units]
In Commercial Distribution
GS140383790003368 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2019-12-11
Device Publish Date2016-09-16

On-Brand Devices [NIPRO SOLUTION INFUSION SET]

10383790005743IS-01-A/A-21G/NV
40383790005737IS-01-A/A-21GS 
10383790003374IS-01-A/A-21G/BL
10383790003367IS-01-A/A-21G
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