FDA.reportPublic FDA data

AP220-01 MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE AND 1.2μ

Primary DI
17290109150366
Brand
AP220-01 MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE AND 1.2μ
Company
EITAN MEDICAL LTD
Model
12003-000-0036
Catalog number
12003-000-0036
Published
2016-09-01
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141834000SAPPHIRE ADMINISTRATION SETQ Core Medical , Ltd.2014-08-05FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290109150363PackageGS130In Commercial Distribution
17290109150366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729010915036327290109150363
1729010915036617290109150366

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
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-241-4002sapphireGCM@icumed.com

Regulatory Flags#

DUNS number
533108028
Device count
1
Lot or batch
true
Manufacturing 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
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
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
08498840010266Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010372Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010389Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30