FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160355540
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA3004
Catalog number
DYNDA3004
Device description
TRACH CARE KIT
Published
2022-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00653160355543PackageGS116In Commercial Distribution
10653160355540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160355543006531603555436531603555430653160355543
1065316035554010653160355540

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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
00840117309661Resp-O2 Tracheostomy Care Kit, One-Compartment tray w/ Vinyl GlovesDynarex CorporationLRQ2022-10-03
00840117309685Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray w/ Vinyl GlovesDynarex CorporationLRQ2022-10-03
00840117309708Resp-O2 Tracheostomy Care Kit, 2-Comp Tray,14 FR Suction CatheterDynarex CorporationLRQ2022-10-03
00840117321359Resp-O2 Tracheostomy Care Kit, Two-Compartment Tray with Removable Plastic BasinDynarex CorporationLRQ2022-10-03
00840117321366Resp-O2 Tracheostomy Care Kit, Two Compartment Tray w/ Removable Plastic BasinDynarex CorporationLRQ2022-10-03
00840117321373Resp-O2 Tracheostomy Care Kit, 3-Compartment Trayw/ Saline & Hydrogen PeroxideDynarex CorporationLRQ2022-10-03
00840117321380Resp-O2 Tracheostomy Care Kit,3-Compartment Tray w/ Hydrogen PeroxdieDynarex CorporationLRQ2022-10-03
00840117321403Resp-O2 Tracheostomy Care Kit,1-Compartment Tray without GlovesDynarex CorporationLRQ2022-10-03
00840117321410Resp-O2 Tracheostomy Care Kit, One-Compartment Mini-Tray, Sterile Dynarex 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