FDA.reportPublic FDA data

Infusion Set for Single Use

Primary DI
06970440020026
Brand
Infusion Set for Single Use
Company
Shinva Ande Healthcare Apparatus Co., Ltd
Model
AD0102
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
06970440020132PackageGS150In Commercial Distribution
06970440020149PackageGS16In Commercial Distribution
06970440020026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970440020132069704400201326970440020132
06970440020149069704400201496970440020149
06970440020026069704400200266970440020026

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

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07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
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