FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160355543
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
OTC
false
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.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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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 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
10653160246466CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160251064CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160256908CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02