FDA.reportPublic FDA data

AP426-01

Primary DI
27290109155283
Brand
AP426-01
Company
EITAN MEDICAL LTD
Model
12003-000-0025
Device description
NFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, SLIDE CLAMP AND SPIN MALE LUER LOCK
Published
2024-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
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
27290109155283PackageGS130In Commercial Distribution
17290109155286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729010915528327290109155283
1729010915528617290109155286

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533108028
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
true
No natural rubber latex
false
Sterilization required before use
false

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
17290109152728Eitan Medical 12222-000-00022024-11-19

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