FDA.reportPublic FDA data

BREEZE® INTRODUCER KIT

Primary DI
30884908139342
Brand
BREEZE® INTRODUCER KIT
Company
Medical Components, Inc.
Model
BINTSS
Catalog number
BINTSS
Device description
BREEZE® INTRODUCER KIT
Published
2022-02-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFLPercutaneous sheath introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFLPercutaneous Sheath Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884908139342PackageGS15In Commercial Distribution
50884908139346PackageGS15In Commercial Distribution
00884908139341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088490813934230884908139342
5088490813934650884908139346
00884908139341008849081393418849081393410884908139341

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(215)256-4201clinical@medcompnet.com

Regulatory Flags#

DUNS number
038000253
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50884908183912SLX Hemo-Cath®MC061405MC0614052026-03-21
50884908183943SLX Hemo-Cath®MC061404MC0614042026-03-21
50884908187620SLX Hemo-Cath®MC061424MBMC061424MB2026-03-21
50884908187637SLX HEMO-CATH®MC061425MBMC061425MB2026-03-21
30884908188456MICRO-STICK SETDMRAH190411DMRAH1904112026-02-19
30884908188463MICRO-STICK SETDMRAH190421DMRAH1904212026-02-19
50884908188474MICRO-STICK SETDMRAH190511DMRAH1905112026-02-19
50884908188481MICRO-STICK SETDMRAH190521DMRAH1905212026-02-19
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28036301MD280363012026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037201MD280372012026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037101MD280371012026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)MR28036304MR280363042026-02-17
50884908152703PRO-PICC® CTMD17035201MD170352012026-02-17
50884908154714PRO-PICC® CTMD17036201MD170362012026-02-17
50884908154721PRO-PICC® CTMD17036301MD170363012026-02-17
50884908160234PRO-PICC® CTMD17035101MD170351012026-02-17
50884908160258PRO-PICC® CTMD17034101MD170341012026-02-17
50884908174361PRO-PICC® CTMD17035105MD170351052026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMD17013101MD170131012026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMD17013105MD170131052026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841268110059Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10841268110097TVS LPAGALT MEDICAL CORP.OFL2026-01-19
10841268110127TVS LPAGALT MEDICAL CORP.OFL2026-01-19
10841268110349Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10841268110387Micro-Introducer KitGALT MEDICAL CORP.OFL2026-01-19
10810050855805Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
H965459001Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459011Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459021Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459151Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459161Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459171Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459181Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
20886333227550ClosureFast Micro Puncture ARGON MEDICAL DEVICES, INC.OFL2024-07-29
20886333227567ClosureFast Micro PunctureARGON MEDICAL DEVICES, INC.OFL2024-07-29
50197106004058CARDINAL HEALTHCardinal Health 200, LLCOFL2022-10-27
10841268109800Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109817Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109824Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109831Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109848Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109855Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109862Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109879Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109886Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109893Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109909Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109916Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109923Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15
10841268109930Elite Transitionless Micro-Introducer KitGALT MEDICAL CORP.OFL2022-08-15