FDA.reportPublic FDA data

blue endo

Primary DI
14714127863181
Brand
blue endo
Company
UNIMAX MEDICAL SYSTEMS INC.
Model
70-7050F1
Device description
Smoke evacuation tubing
Published
2024-06-20
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

Product Codes#

Code, Name table
CodeName
FCZTube, Smoke Removal, Endoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCZTube, Smoke Removal, EndoscopicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14714127863181PackageGS110In Commercial Distribution
24714127863188PackageGS16In Commercial Distribution
04714127863184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471412786318114714127863181
2471412786318824714127863188
04714127863184047141278631844714127863184

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic plume filterA sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658122465
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15055515601558FemcareFN-100-105 2025-10-14
15055515601565FemcareFN-100-1062025-10-14
15055515601572FemcareFN-100-1072025-10-14
15055515601602FemcareFN-100-2092025-10-14
15055515601619FemcareFN-100-2102025-10-14
15055515601626FemcareFN-100-2112025-10-14
15055515602401FemcareFN-100-106-CA2025-10-14
15055515602418FemcareFN-100-210-CA2025-10-14
04714127861500UnimaxFEPC340802025-02-06
14714127861507UnimaxFEPC340802025-02-06
14714127866601UnimaxFPJ1330592021-08-10
14714127866700UnimaxFPL1330592021-08-10
14714127866809UnimaxFPS1330592021-08-10
04714127860732CONMED12222019-12-17
04714127860879CONMED12212019-12-17
04714127862972Monopolar scissorsFMS4330562018-04-02
04714127862996Monopolar scissorsFMS4330552017-11-29
04714127865980Monopolar scissorsFMS3330502017-09-18
04714127866000UnimaxFMS5330502020-11-18
04714127866239UnimaxFEC5330502021-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060768280576SESISSURGEASE INNOVATIONS LIMITEDFCZ2026-05-09
00850003294841GynexJOSNOE MEDICAL, INC.FCZ2024-11-08
00850003294834GynexJOSNOE MEDICAL, INC.FCZ2024-11-08
04714127863184blue endoUNIMAX MEDICAL SYSTEMS INC.FCZ2024-06-20
00840306828393Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828409Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828416Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828423Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306828430Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-05-20
00840306822780Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822797Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822803Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822810Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822827Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822841Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822858Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822896Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-18
00840306822759Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
00840306822766Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.FCZ2024-04-16
GYNX80091GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80241GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80721GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81001GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX81031GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX82001GynexGYNEX CORPORATIONFCZ2023-12-19
GYNX80090GynexGYNEX CORPORATIONFCZ2023-12-19