FDA.report

Deluxe Closed Suction System 72hr

Primary DI
00848530095765
Brand
Deluxe Closed Suction System 72hr
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
VEN368160
Device description
"Deluxe CSS, Adult, 72-hours, Tracheostomy, 305mm, 16Fr, 1-hand switch, with Wedge + Adapte"
Published
2024-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications

CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848530095765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530095765008485300957658485300957650848530095765

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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