FDA.reportPublic FDA data

175IBLSSC

Primary DI
28053323800020
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
Rx
false
OTC
false
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. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
513976688
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053323800026175IBLSSC175IBLSSC2019-02-26
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