Sealing Connector T piece

GUDID 05906168942259

The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass through while preventing blood or other fluids from leaking out. It is designed to maintain a seal around the inserted instruments.

WISMED PL SP Z O O

Haemostasis valve
Primary Device ID05906168942259
NIH Device Record Key2c4a552f-8d22-471e-9cb4-12e89fdfed96
Commercial Distribution StatusIn Commercial Distribution
Brand NameSealing Connector T piece
Version Model Number1
Company DUNS850665825
Company NameWISMED PL SP Z O O
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com
Phone+1 (513) 604-3430
Emailinfo@acemedicalco.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105906168942259 [Primary]

FDA Product Code

EYKConnector, Ureteral Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-25
Device Publish Date2025-03-17

Devices Manufactured by WISMED PL SP Z O O

05906168942228 - Dual Action Pump Hand2025-04-04 The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract
05906168942211 - Dual Action Pump Foot2025-03-25 The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract
05906168942235 - Sealing Connector Y piece2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro
05906168942242 - Sealing Connector I Piece 2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro
05906168942259 - Sealing Connector T piece2025-03-25The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass through while preventing blood or other fluids from leaking out. It is designed to maintain a seal around the inserted instruments.
05906168942259 - Sealing Connector T piece2025-03-25 The Sealing Connectors are a haemostatic valves used in minimally invasive procedures. The valves allow instruments to pass thro
16009900408313 - Peditrol2025-03-25 Peditrol is a foot-operated irrigation system that is used during Ureterorenoscopy to facilitate irrigation and manipulation of
06009900408330 - Smart Bulb2025-03-25 Smart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and help
06009900408439 - Mini Pillow2025-03-25 Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigat

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.