FDA.report

Resp-O2 Closed Suction Endotracheal Catheter

Primary DI
00840117318151
Brand
Resp-O2 Closed Suction Endotracheal Catheter
Company
DYNAREX CORPORATION
Model
31020
Device description
Resp-O2 Closed Suction Endotracheal Catheter, 10FR w. T-piece, adult/pediatric
Published
2021-04-22
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
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications

CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117318151PackageGS12In Commercial Distribution
00840117338906PackageGS110In Commercial Distribution
00840117318144PrimaryGS10
00840117319738Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117318151008401173181518401173181510840117318151
00840117338906008401173389068401173389060840117338906
00840117318144008401173181448401173181440840117318144
00840117319738008401173197388401173197380840117319738

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
008124539
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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