FDA.report

Centurion

Primary DI
00653160256901
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
TC7785
Catalog number
TC7785
Device description
TRACHEOSTOMY SET
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

Related Records

Contact Domains

Product Codes

CodeName
LRQTracheostomy and nasal suctioning kit

Product Code Classifications

CodeDeviceSpecialtyClass
LRQTracheostomy And Nasal Suctioning KitUnknown1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160256901PackageGS16In Commercial Distribution
10653160256908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160256901006531602569016531602569010653160256901
1065316025690810653160256908

GMDN Terms

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

Contacts

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

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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
10653160020516CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
20653160028779CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160031275CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02
50653160031299CenturionCENTURION MEDICAL PRODUCTS CORPORATIONLRQ2022-01-02