FDA.reportPublic FDA data

175IBLSSC

Primary DI
08053323800026
Brand
175IBLSSC
Company
ELCAM MEDICAL ITALY SPA
Model
175IBLSSC
Device description
Catheter Injection port
Published
2019-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCEAdaptor, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCEAdaptor, CatheterGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K855039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K855039000MEDIFLEX INJECTION CAPMediflex Intl.1986-01-24GCE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18053323800023PackageGS1100In Commercial Distribution
28053323800020PackageGS11000In Commercial Distribution
08053323800026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805332380002318053323800023
2805332380002028053323800020
08053323800026080533238000268053323800026

GMDN Terms#

Term, Definition table
TermDefinition
Catheter injection portA device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. Some types may be designed as a Y-connector with an additional inlet (e.g., with a female Luer connection point) to facilitate sequential injection and infusion of fluids (e.g., medication followed by saline). It may be additionally intended for use as a heparin/saline lock by keeping the flush solution in the catheter. This is a single-use device.

Regulatory Flags#

DUNS number
513976688
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28053323800020175IBLSSC175IBLSSC2019-02-26
0805332380001907103300/S07103300/S2016-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04044503008145FUJIFILM medworkFUJIFILM medwork GmbHGCE2026-03-31
06932503562256Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
16932503562253Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2025-04-30
00850052377007CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054918CLR PortCLR MedicalGCE2024-05-29
00860003054994CLR Port CapCLR MedicalGCE2024-05-29
00850052377021CLR Port InjectorCLR MedicalGCE2024-05-29
00860003054956CLR PortCLR MedicalGCE2024-05-29
00850052377014CLR Port CapCLR MedicalGCE2024-05-29
00887709078017ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00887709078024ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078014ICU MedicalICU MEDICAL, INC.GCE2023-08-30
10887709078021ICU MedicalICU MEDICAL, INC.GCE2023-08-30
00827002226760COOKCOOK INCORPORATEDGCE2022-12-08
00827002226777COOKCOOK INCORPORATEDGCE2022-12-08
M7525250520STRADIS HEALTHCARESTRADIS MEDICAL, LLCGCE2022-03-09
06932503562218Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562225Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562232Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562249Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562263Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562270Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562287Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562294Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
06932503562300Spray CatheterMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562215MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562222MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562239MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562246MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31
16932503562260MTMicro-Tech (Nanjing) Co., Ltd.GCE2021-12-31