FDA.reportPublic FDA data

Tracheostomy and Suction Accessory

Primary DI
00848530106249
Brand
Tracheostomy and Suction Accessory
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
VEN77230510M
Device description
Adult 72hr Closed Suction Catheter Tracheostomy - 10Fr 305mm
Published
2025-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GYCElectrode, Cortical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYCElectrode, CorticalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530106246PackageGS110In Commercial Distribution
20848530106243PackageGS16In Commercial Distribution
00848530106249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853010624610848530106246
2084853010624320848530106243
00848530106249008485301062498485301062490848530106249

GMDN Terms#

Term, Definition table
TermDefinition
Closed-suction breathing circuit connector/switchA sterile length of tube with valves intended to create a closed three-way connection between an endotracheal tube, a ventilator/anaesthesia unit, and a suction pump to eliminate the need to disconnect the breathing circuit for secretion suctioning. The valves are intended to be manually-operated to isolate parts of the circuit and control suction, and the device may include a port(s) for the administration of fluids such as saline. This is a single-use device.

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
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
00848530107451Stratus Power SwitchRP0762025-09-24
00848530107468Stratus Pneumatic ValveRP0772025-09-24
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04
00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
00848530108328Repair PartsRP0932026-06-03
00848530109097CPAP MaskCM060S2026-06-03
00848530109264CPAP MaskCM060M2026-06-03
00848530109271CPAP MaskCM060L2026-06-03
00848530109288CPAP MaskCM060XL2026-06-03
00848530108953Repair PartsRP1082026-06-02
00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
00848530109011Repair PartsRP1112026-06-02
00848530109028Repair PartsRP1122026-06-02

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Primary DI, Brand, Company table
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00650551006671CORTAC®PMT CORPORATIONGYC2026-06-04
00650551006688CORTAC®PMT CORPORATIONGYC2026-06-04
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00650551006114CORTAC®PMT CORPORATIONGYC2026-05-18
00650551005858CORTACPMT CORPORATIONGYC2026-05-15
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00840067103029ZenithCADWELL INDUSTRIES, INC.GYC2025-12-31
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10848530106192Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
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