Dual Action Pump Hand

Primary DI
59061689422282
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
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
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
59061689422282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5906168942228259061689422282

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

Regulatory Flags#

DUNS number
850665825
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
05906168942228Dual Action Pump Hand12025-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453040756Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFFD2025-08-25
05906168942228Dual Action Pump HandWISMED PL SP Z O OFFD2025-03-17
05906168942211Dual Action Pump FootWISMED 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
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