FDA.reportPublic FDA data

Centurion

Primary DI
10653160020516
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
TC435
Catalog number
TC435
Device description
TRACHEOSTOMY CARE TRAY
Published
2022-01-02
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
10653160020516PackageGS116In Commercial Distribution
00653160020519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316002051610653160020516
00653160020519006531600205196531600205190653160020519

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(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags#

DUNS number
017246562
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
00653160294248CenturionMNS101552016-11-11
00653160315974CenturionCIT66352018-04-09
00653160284218CenturionCIT59202017-03-03
00653160274882CenturionPE31802018-02-11
00653160389753CenturionDM485BDM485B2025-09-17
00653160389296CenturionBT235BBT235B2025-08-24
00653160389319CenturionCSS640ACSS640A2025-08-24
00653160389494CenturionDT23104DT231042025-08-24
00653160388992CenturionSUT14785ASUT14785A2025-08-18
00653160389357CenturionDT23103DT231032025-08-18
00653160389067CenturionDYNDV2722DYNDV27222025-08-09
00653160389074CenturionSUT19525ASUT19525A2025-08-09
00653160389159CenturionIVS1090BIVS1090B2025-08-09
00653160388978CenturionMNS10875BMNS10875B2025-08-02
00653160386936CenturionIVS4222IVS42222025-07-21
00653160388909CenturionSUT21465BSUT21465B2025-07-21
00653160388848CenturionDYNDC3166DDYNDC3166D2025-07-18
00653160388732CenturionSUT19955BSUT19955B2025-07-14
00653160388770CenturionDM875ADM875A2025-07-14
00653160388794CenturionSUT12485ASUT12485A2025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063139434Neil Medical Group Neil Medical GroupLRQ2025-12-08
00653160387292MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387377MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387384MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
00653160387391MEDLINEMEDLINE INDUSTRIES, INC.LRQ2025-04-12
30840330705425ProCureTwin Med, LLCLRQ2025-01-20
30840330704244ProCureTwin Med, LLCLRQ2024-03-25
30840330704251ProCureTwin Med, LLCLRQ2024-03-25
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, 2-Compartment Tray, Vinyl GlovesDYNAREX CORPORATIONLRQ2022-10-03
00840117321366Resp-O2 Tracheostomy Care Kit, Two Compartment Tray w /Nitrile GlovesDYNAREX CORPORATIONLRQ2022-10-03
00840117321373Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray, Nitrile GlovesDYNAREX CORPORATIONLRQ2022-10-03
00840117321380Resp-O2 Tracheostomy Care Kit, 3-Compartment Tray, Vinyl GlovesDYNAREX CORPORATIONLRQ2022-10-03
00840117321403Resp-O2 Tracheostomy Care Kit, 1-Compartment Tray without GlovesDYNAREX CORPORATIONLRQ2022-10-03
00840117321410Resp-O2 Tracheostomy Care Kit, 1-Compartment Mini-TrayDYNAREX CORPORATIONLRQ2022-10-03
00653160355543MEDLINEMEDLINE INDUSTRIES, INC.LRQ2022-10-03
10653160006770CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160007753CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160009467CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160010171CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160017668CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160017699CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
10653160017721CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
20653160028779CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160031275CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160031299CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160031305CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02