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
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
10887709175980ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709175997ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709176000ICU Medical, Inc.ICU MEDICAL, INC.DRS2026-02-16
10887709128092ICU Medical, Inc.ICU MEDICAL, INC.DRS2025-04-08
08886483503854ACCUTRANS™ Disposable Pressure Monitoring SystemBIOPTIMAL INTERNATIONAL PTE. LTD.DRS2025-01-22
00690103201079Acumen IQEdwards Lifesciences LLCDRS2024-09-23
50690103200930Acumen IQEdwards Lifesciences LLCDRS2024-08-27
50690103200954Acumen IQEdwards Lifesciences LLCDRS2024-08-27
50690103200978ACUMEN IQ SENSOREdwards Lifesciences LLCDRS2024-08-27
00690103201093Acumen IQEdwards Lifesciences LLCDRS2024-08-27
00690103201109ACUMEN IQ SENSOREdwards Lifesciences LLCDRS2024-08-27
00840619028152Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619037185Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619045104Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619065102Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619067212Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00840619097257Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709044838Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045255Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045293Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709045460Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709070684Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709089280Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709121416Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127494Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127500Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127517Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127524Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127531Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127548Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20