FDA.reportPublic FDA data

Infusion Set for Single Use

Primary DI
06970440020071
Brand
Infusion Set for Single Use
Company
Shinva Ande Healthcare Apparatus Co., Ltd
Model
AD0401
Published
2018-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K162601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162601000Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd.2017-05-31FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970440020231PackageGS140In Commercial Distribution
06970440020248PackageGS16In Commercial Distribution
06970440020071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970440020231069704400202316970440020231
06970440020248069704400202486970440020248
06970440020071069704400200716970440020071

GMDN Terms#

Term, Definition table
TermDefinition
Electronic gravity infusion controller administration setA collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
421062164
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16941512150887Disposable IV CatheterIVC07-142023-05-08
16941512150894Disposable IV CatheterIVC07-162023-05-08
16941512150900Disposable IV CatheterIVC07-182023-05-08
16941512150917Disposable IV CatheterIVC07-202023-05-08
16941512150924Disposable IV CatheterIVC07-222023-05-08
16941512150931Disposable IV CatheterIVC07-242023-05-08
16941512150948Disposable IV CatheterIVC07-262023-05-08
16941512151020Disposable IV CatheterIVC09-142023-05-08
16941512151037Disposable IV CatheterIVC09-162023-05-08
16941512151044Disposable IV CatheterIVC09-182023-05-08
16941512151051Disposable IV CatheterIVC09-202023-05-08
16941512151068Disposable IV CatheterIVC09-222023-05-08
16941512151075Disposable IV CatheterIVC09-242023-05-08
16941512151082Disposable IV CatheterIVC09-262023-05-08
36941512150881Disposable IV CatheterIVC07-142023-05-08
36941512150898Disposable IV CatheterIVC07-162023-05-08
36941512150904Disposable IV CatheterIVC07-182023-05-08
36941512150911Disposable IV CatheterIVC07-202023-05-08
36941512150928Disposable IV CatheterIVC07-222023-05-08
36941512150935Disposable IV CatheterIVC07-242023-05-08

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