FDA.reportPublic FDA data

AV1027-01 Avoset Microbore set 12222-000-1027

Primary DI
17290109155996
Brand
AV1027-01 Avoset Microbore set 12222-000-1027
Company
EITAN MEDICAL LTD
Model
12222-000-1027
Catalog number
AV1027-01
Device description
MICROBORE INFUSION SET WITH FEMALE LUER LOCK, ADMINISTRATION CASSETTE WITH FREE-FLOW PROTECTION, SLIDE CLAMP, DSPR, AND MALE LUER LOCK WITH BACK CHECK VALVE.
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K213744000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213744000Avoset Infusion Pump SystemEitan Medical , Ltd.2023-03-10FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290109155993PackageGS120In Commercial Distribution
17290109155996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729010915599327290109155993
1729010915599617290109155996

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 Temperature5 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

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

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08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
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