NIPRO SOLUTION INFUSION SET

GUDID 40383790005737

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 ID40383790005737
NIH Device Record Keya8dc3dc3-8311-4e82-bcd8-831f08eaaaa7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIPRO SOLUTION INFUSION SET
Version Model NumberIS-01-A/A-21GS 
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
GS100383790005739 [Primary]
GS110383790005736 [Package]
Contains: 00383790005739
Package: [100 Units]
In Commercial Distribution
GS140383790005737 [Package]
Contains: 10383790005736
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.