FDA.report

Centurion

Primary DI
00653160288339
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CLPH2O001-5
Published
2016-09-10
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
00653160288339PackageGS15In Commercial Distribution
10653160288336PackageGS15In Commercial Distribution
20653160288333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160288339006531602883396531602883390653160288339
1065316028833610653160288336
2065316028833320653160288333

GMDN Terms

TermDefinition
Cerebrospinal fluid manometer, battery-poweredA sterile, noninvasive, battery-powered device designed to measure the cerebrospinal fluid (CSF) pressure/intracranial pressure via lumbar puncture. It is a small housing with an integrated transducer and pressure display intended to be connected to separate invasive CSF access devices (e.g., catheter, cannula, needle) which are inserted into the subarachnoid (intrathecal) space of the lumbar region of the spinal column. 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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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

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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
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