FDA.reportPublic FDA data

NIPRO SOLUTION INFUSION SET

Primary DI
10383790003367
Brand
NIPRO SOLUTION INFUSION SET
Company
NIPRO MEDICAL CORPORATION
Model
IS-01-A/A-21G
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101958000AMSINO I.V. ADMINISTRATION AND EXTENSION SETSAmsino International, Inc.2010-09-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383790003367PackageGS1100In Commercial Distribution
40383790003368PackageGS14In Commercial Distribution
00383790003360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038379000336710383790003367
4038379000336840383790003368
00383790003360003837900033603837900033600383790003360

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(908) 393-7030info@nipromed.com

Regulatory Flags#

DUNS number
797372554
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383790011839PRESSONETRG001-000-000-0012026-05-01
00383790012478relasyringe SYPR-03GA-WPSYPR-03GA-WP6; SYPR-03GA-WP602026-05-01
00383790012515relasyringe SYPR-03GA-WP-S-USSYPR-03GA-WP6-S-US; SYPR-03GA-WP60-S-US2026-05-01
00383790008037Nipro SafeTouch NeedleSAH+1825-1M2026-04-30
00383790008105Nipro SafeTouch NeedleSAH+2138-1M2026-04-30
00383790008136Nipro SafeTouch NeedleSAH+2238-1M2026-04-30
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
40383790012377Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
40383790012384Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
40383790012391Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
40383790012407Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
40383790012414Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
00383790004503NIPRO TP-SURETPSURE+12015-09-16
00383790011877SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A226Y/V813-NIJ2025-06-01
00383790011884NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A217Y/V806-NIJ2025-06-01
00383790011891NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A209Y/V803-NIJ2025-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624601253Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921207Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921214Q2 Blood Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624921238Q2 Blood Administration SetsQUEST MEDICAL INCFPA2022-12-06
00634624921122High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-06
00634624921115High-Flow 4-Way Stopcock ExtensionQUEST MEDICAL INCFPA2022-12-05
00634624911062Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-10-26
00634624921382Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921399Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921405Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921412Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921429Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921436Precision Delivery IV Extension SetQUEST MEDICAL INCFPA2022-09-15
00634624921016Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921023Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921030Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921061Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624921078Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24
00634624922044Precision Delivery IV Extension Set, AmberQUEST MEDICAL INCFPA2021-06-24