FDA.reportPublic FDA data

Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile

Primary DI
00840117321410
Brand
Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile
Company
Dynarex Corporation
Model
35009
Device description
"(1) One-compartment mini-tray(2) Non-woven gauze, 4"" × 4""(2) Tracheostomy dressing(2) Cotton-tipped applicators(2) Pipe cleaners(1) 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
00840117321489PackageGS140In Commercial Distribution
00840117321410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117321489008401173214898401173214890840117321489
00840117321410008401173214108401173214100840117321410

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"10111-62026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"10112-62026-07-31
00840117346253Pill Crusher Pouches with Round Corners4210R2026-07-31
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 22881562026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"81672026-07-31
00840117351684Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag50032026-07-31
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter32000S2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063139434Neil Medical Group Neil Medical GroupLRQ2025-12-08
10653160387299MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
10653160387374MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
10653160387381MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
10653160387398MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387292MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387377MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387384MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387391MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
10840330705421ProCureTwin Med, LLCLRQ2025-01-20
30840330705425ProCureTwin Med, LLCLRQ2025-01-20
10840330704240ProCureTwin Med, LLCLRQ2024-03-25
10840330704257ProCureTwin Med, LLCLRQ2024-03-25
30840330704244ProCureTwin Med, LLCLRQ2024-03-25
30840330704251ProCureTwin Med, LLCLRQ2024-03-25
10195594838119CARDINAL HEALTHCardinal Health 200, LLCLRQ2023-07-07
50195594838117CARDINAL HEALTHCardinal Health 200, LLCLRQ2023-07-07
10653160355540MEDLINEMEDLINE INDUSTRIES, INC.LRQ2022-10-03
00840117309661Resp-O2 Tracheostomy Care Kit, One-Compartment Tray With Vinyl GlovesDynarex CorporationLRQ2022-10-03
00840117309685Resp-O2 Tracheostomy Care Kit, Three-Compartment Tray With Vinyl GlovesDynarex CorporationLRQ2022-10-03
00840117309708Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321359Resp-O2 Tracheostomy Care Kit, Two-Compartment Tray with Removable Plastic BasinDynarex CorporationLRQ2022-10-03
00840117321366Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321373Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321380Resp-O2 Tracheostomy Care KitDynarex CorporationLRQ2022-10-03
00840117321403Resp-O2 Tracheostomy Care Kit One-Compartment Tray Without GlovesDynarex CorporationLRQ2022-10-03
00653160355543MEDLINEMEDLINE INDUSTRIES, INC.LRQ2022-10-03
10653160246466CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160251064CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160256908CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02