FDA.reportPublic FDA data

AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA

Primary DI
17290109153060
Brand
AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA
Company
EITAN MEDICAL LTD
Model
12005-000-0003
Published
2022-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFANon-Invasive Central Venous Manometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFANon-Invasive Central Venous ManometerCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192860000Sapphire Infusion Pump, Sapphire administration setsQ Core Medical , Ltd.2020-11-19FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290109153067PackageGS130In Commercial Distribution
17290109153060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729010915306727290109153067
1729010915306017290109153060

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
949.288.5482customerservice@eitanmedical.com

Regulatory Flags#

DUNS number
533108028
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290109156009AP504-0112000-000-00452026-05-07
17290109156016AP433-0112000-000-00442026-05-05
17290109155972AV1029-01 Avoset Microbore set 12222-000-102912222-000-1029AV1029-012026-04-14
17290109155996AV1027-01 Avoset Microbore set 12222-000-102712222-000-1027AV1027-012026-04-14
17290109152704AV1016-01 Avoset 250mL Medication Reservoir Pouch12222-000-1016AV1016-012025-08-31
17290109152766AV1010-01 Minibore Extension Set12222-000-10102025-05-29
27290109152640AV1010-01 Minibore Extension Set12222-000-10102025-05-29
17290109152742Avoset Kit - US17000-036-00042025-03-05
17290109155217AP209-0112003-000-10272025-03-05
27290109152749Avoset Kit - US17000-036-00042025-03-05
27290109155214AP209-0112003-000-10272025-03-05
17290109155873AP414-0112003-000-00212025-02-10
27290109155870AP414-0112003-000-00212025-02-10
17290109152674AV1017-01 Avoset 50ML Medication Reservoir12222-000-10172025-02-03
27290109152688AV1017-01 Avoset 50ML Medication Reservoir12222-000-10172025-02-03
17290109155880AP434-0112000-000-003012000-000-00302025-01-27
27290109155887AP434-0112000-000-003012000-000-00302025-01-27
17290109155286AP426-0112003-000-00252024-11-30
07290109155296Sapphire PCA Lockbox 500mL Label 15062-131-00102024-11-29
27290109155283AP426-0112003-000-00252024-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
27290109153067AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VAQ-CORE MEDICAL LTDPFA2022-05-15
M9833340000101Mespere Mespere LifeSciences IncPFA2016-10-06
M9831101000041Mespere Mespere LifeSciences IncPFA2016-10-06
M9831102000011Mespere Mespere LifeSciences IncPFA2016-10-06
M9831104000021Mespere Mespere LifeSciences IncPFA2016-10-06
M9831104000031Mespere Mespere LifeSciences IncPFA2016-10-06
M9831105000061Mespere Mespere LifeSciences IncPFA2016-10-06
M9831106000021Mespere Mespere LifeSciences IncPFA2016-10-06
M9831107000031Mespere Mespere LifeSciences IncPFA2016-10-06
M9831108000021Mespere Mespere LifeSciences IncPFA2016-10-06
M9831108000031Mespere Mespere LifeSciences IncPFA2016-10-06
M9831109000011Mespere Mespere LifeSciences IncPFA2016-10-06