FDA.reportPublic FDA data

Dual Action Pump Hand

Primary DI
05906168942228
Brand
Dual Action Pump Hand
Company
WISMED PL SP Z O O
Model
1
Device description
The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract during stone management, while simultaneously draining the same volume.
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFDEvacuator, Bladder, Manually Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFDEvacuator, Bladder, Manually OperatedGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05906168942228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05906168942228059061689422285906168942228

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (513) 604-3430info@acemedicalco.com
+1 800.822.0314info@acemedicalco.com

Regulatory Flags#

DUNS number
850665825
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009900408316Peditrol12025-03-17
05906168942211Dual Action Pump Foot12025-03-17
05906168942235Sealing Connector Y piece12025-03-17
05906168942242Sealing Connector I Piece 12025-03-17
05906168942259Sealing Connector T piece12025-03-17
16009900408313Peditrol12025-03-17
06009900408330Smart Bulb12025-03-17
06009900408439Mini Pillow12025-03-17
06009900639604Another Hand12025-03-17
59061689422282Dual Action Pump Hand12025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453040756Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFFD2025-08-25
05906168942211Dual Action Pump FootWISMED PL SP Z O OFFD2025-03-17
59061689422282Dual Action Pump HandWISMED PL SP Z O OFFD2025-03-17
00810143891249Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2024-09-27
00810143891256Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFD2024-09-27
06936881168789Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
06936881168796Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
06936881168802Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168783Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168790Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
26936881168806Wellead EvacuatorWell Lead Medical Co.,LtdFFD2024-01-19
00190776299668MillenniumAvalign Technologies, Inc.FFD2023-06-23
05060460843666EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843697EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843727EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843758EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460845707EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460848043EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889374EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889404EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889435EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843680EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843710EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843741EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460843765EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460845714EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060460848050EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889398EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889428EnteralGBUK ENTERAL LIMITEDFFD2022-10-19
05060590889442EnteralGBUK ENTERAL LIMITEDFFD2022-10-19