FDA.report

Resp-O2 Closed Suction Tracheostomy Catheter

Primary DI
00840117319554
Brand
Resp-O2 Closed Suction Tracheostomy Catheter
Company
DYNAREX CORPORATION
Model
31000
Device description
Resp-O2 Closed Suction Tracheostomy Catheter, 10 FR 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
00840117319554PackageGS12In Commercial Distribution
00840117338821PackageGS110In Commercial Distribution
00840117319547PrimaryGS10
00810180840675Unit of UseGS10
00840117319530Unit of UseGS10
08401173195470Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117319554008401173195548401173195540840117319554
00840117338821008401173388218401173388210840117338821
00840117319547008401173195478401173195470840117319547
00810180840675008101808406758101808406750810180840675
00840117319530008401173195308401173195300840117319530
08401173195470084011731954708401173195470

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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