FDA.reportPublic FDA data

Resp-O2 Tracheostomy Care Kit, 3-Compartment Trayw/ Saline & Hydrogen Peroxide

Primary DI
00840117321373
Brand
Resp-O2 Tracheostomy Care Kit, 3-Compartment Trayw/ Saline & Hydrogen Peroxide
Company
Dynarex Corporation
Model
35005
Device description
"Nitrile Gloves, STERILE-EO(1) Three-compartment tray(1) Pair of nitrile gloves(1) 3-Ply waterproof drape(4) Non-woven gauze, 4"" × 4""(1) Tracheostomy dressing(2) Cotton-tipped applicators(1) Twill tape(2) Pipe cleaners(1) Tracheostomy brush(1) Sterile saline 0.9%, 100 mL(2) Hydrogen peroxide 1 oz. pack"
Published
2022-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRQTracheostomy And Nasal Suctioning Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRQTracheostomy And Nasal Suctioning KitUnknown1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117321441PackageGS120In Commercial Distribution
00840117321373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117321441008401173214418401173214410840117321441
00840117321373008401173213738401173213730840117321373

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy care kit, single-useA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

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