FDA.reportPublic FDA data

Infusion Set for Single Use

Primary DI
06970440020248
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
Rx
false
OTC
false
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
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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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00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
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