FDA.reportPublic FDA data

Centurion

Primary DI
00653160291315
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
MNS9930
Catalog number
MNS9930
Device description
TRACHEOSTOMY KIT
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
LROGeneral Surgery Tray
LRQTracheostomy and nasal suctioning kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
LRQTracheostomy And Nasal Suctioning KitUnknown1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160291315PackageGS16In Commercial Distribution
10653160291312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160291315006531602913156531602913150653160291315
1065316029131210653160291312

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. 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
true
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
10653160393757CENTURIONCIT5215ACIT5215A2026-05-27
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233017276Busse Hospital DisposablesROBERT BUSSE & CO., INC.LRO2026-05-28
10809160522059HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522073HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522080HalyardAVID MEDICAL, INC.LRO2026-05-28
10885632522079SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-05-28
10653160393702MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-05-27
10653160393757CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-05-27
10809160521878HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521885HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521892HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521922HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521939HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521946HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521953HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521960HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521977HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521991HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522004HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522011HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522028HalyardAVID MEDICAL, INC.LRO2026-05-27
H65857028265Henry ScheinHENRY SCHEIN, INC.LRO2022-01-28
H65857028255Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028285Henry ScheinHENRY SCHEIN, INC.LRO2022-01-27
H65857028925Henry ScheinHENRY SCHEIN, INC.LRO2022-01-26
H65857028915Henry ScheinHENRY SCHEIN, INC.LRO2022-01-24
H65857028905Henry ScheinHENRY SCHEIN, INC.LRO2022-01-18
H65857028875Henry ScheinHENRY SCHEIN, INC.LRO2021-12-29
H65857028865Henry ScheinHENRY SCHEIN, INC.LRO2021-12-21
H65857028855Henry ScheinHENRY SCHEIN, INC.LRO2021-12-14
H65857028845Henry ScheinHENRY SCHEIN, INC.LRO2021-12-13