FDA.reportPublic FDA data

Centurion

Primary DI
10653160308416
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CTHR002-5QB
Published
2017-03-23
Public version status
Update
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
DRSTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160308419PackageGS15In Commercial Distribution
10653160308416PackageGS15In Commercial Distribution
20653160308413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160308419006531603084196531603084190653160308419
1065316030841610653160308416
2065316030841320653160308413

GMDN Terms#

Term, Definition table
TermDefinition
Pleural manometerA sterile, noninvasive, battery-powered device intended to convert pressure into electrical signals for the measurement of pressure within the pleural cavity. It is a small housing with an integrated transducer and pressure display intended to be connected to a separate invasive vascular access device (e.g., needle, pleural catheter). It may be used to measure lung elasticity during thoracentesis. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@CENTURIONMP.CO

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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
10653160394068CENTURIONSUT11035ASUT11035A2026-07-21
10653160239369CENTURIONCHT805CHT8052022-01-01
10653160243694CENTURIONSUT17770SUT177702022-01-02
10653160277859CENTURIONSUT19145SUT191452022-01-02
10653160283966CENTURIONCVI4145CVI41452017-08-14
10653160285267CENTURIONMNS9625MNS96252022-01-02
10653160317937CENTURIONTRI66800TRI668002022-01-02
10653160322948CENTURIONSUT20915SUT209152022-01-02
10653160330783CENTURIONSUT21230ASUT21230A2022-01-02
10653160333883CENTURIONSUT18765ASUT18765A2022-01-02
10653160345220CENTURIONMNS13075MNS130752022-01-01
10653160360247CENTURIONMNS7285AMNS7285A2023-05-22
10653160374183CENTURIONMNS11780BMNS11780B2024-05-02
00653160013641CENTURIONMNS1080MNS10802022-01-01
00653160017762CENTURIONUVT235UVT2352022-01-02
00653160191349CENTURIONMNS5555MNS55552022-01-01
00653160199352CENTURIONSUT1243ASUT1243A2022-01-02
00653160200867CENTURIONSUT15260SUT152602022-01-02
00653160228397CENTURIONSUT17155SUT171552022-01-02
00653160130683Centurion589784ST589784ST2022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403531654Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
00885403531678Acumen IQ, VAMPBecton, Dickinson And CompanyDRS2026-05-30
00885403531739Acumen IQBecton, Dickinson And CompanyDRS2026-05-30
08886483502390BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2026-05-04
H6713000060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713000840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100060N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100120N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100180N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100240N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100360N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100480N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100600N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100720N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6713100840N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001010N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001020N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716001220N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6716004000N/AUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23
H6719004920DELTRANUTAH MEDICAL PRODUCTS, INC.DRS2016-09-23