FDA.reportPublic FDA data

Resp-O2 Tracheostomy Care Kit, Two-Compartment Tray with Removable Plastic Basin

Primary DI
00840117321359
Brand
Resp-O2 Tracheostomy Care Kit, Two-Compartment Tray with Removable Plastic Basin
Company
Dynarex Corporation
Model
35003
Device description
"Vinly Gloves ( Sterile-EO ) (1) Two-compartment tray(1) Removable plastic basin(1) Pair of vinyl 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"
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
00840117321427PackageGS120In Commercial Distribution
00840117321359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117321427008401173214278401173214270840117321427
00840117321359008401173213598401173213590840117321359

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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