FDA.reportPublic FDA data

Smart Bulb

Primary DI
06009900408330
Brand
Smart Bulb
Company
WISMED PL SP Z O O
Model
1
Device description
Smart Bulb is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy, and helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Smart Bulb is designed for controlled irrigation through an endoscope or accessory during urological procedures.
Published
2025-03-17
Public version status
New
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
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009900408330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009900408330060099004083306009900408330

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. 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
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
06009900408439Mini Pillow12025-03-17
06009900639604Another Hand12025-03-17
59061689422282Dual Action Pump Hand12025-03-17

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06009900408439Mini PillowWISMED PL SP Z O OFFY2025-03-17
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