Mini Pillow

GUDID 06009900408439

Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigation during endoscopy helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Mini Pillow is designed for controlled irrigation through an endoscope or accessory during urological procedures.

WISMED PL SP Z O O

Surgical irrigation tubing set, single-use
Primary Device ID06009900408439
NIH Device Record Keyb552ba21-a0be-4198-a8cf-3feae8500cdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini Pillow
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+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com
Phone+1 800.822.0314
Emailinfo@acemedicalco.com

Operating and Storage Conditions

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
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS106009900408439 [Primary]
GS116009900408436 [Package]
Package: Box [10 Units]
In Commercial Distribution
GS136009900408430 [Package]
Package: Box [60 Units]
In Commercial Distribution

FDA Product Code

FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

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 piece2025-03-25 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 Pillow2025-03-25Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigation during endoscopy helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Mini Pillow is designed for controlled irrigation through an endoscope or accessory during urological procedures.
06009900408439 - Mini Pillow2025-03-25 Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigat
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