FDA.report

Centurion

Primary DI
10653160290292
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CUHG1-INT
Published
2016-09-07
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

Related Records

Contact Domains

Product Codes

CodeName
DRSTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DRSTransducer, Blood-Pressure, ExtravascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160290295PackageGS15In Commercial Distribution
10653160290292PackageGS15In Commercial Distribution
20653160290299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160290295006531602902956531602902950653160290295
1065316029029210653160290292
2065316029029920653160290299

GMDN Terms

TermDefinition
Invasive-pressure external transducer, single-useA sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.

Sterilization Methods

Method

Contacts

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

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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

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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
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00887709127531Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20
00887709127548Transpac™/Transtar™ICU MEDICAL, INC.DRS2024-08-20