FDA.report

Centurion

Primary DI
10653160125792
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
SXW507
Published
2016-09-14
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
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653160125792PackageGS150In Commercial Distribution
00653160125795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1065316012579210653160125792
00653160125795006531601257956531601257950653160125795

GMDN Terms

TermDefinition
Non-absorbing intravenous administration setA collection of sterile devices designed for the intravenous (IV) administration of solutions and manufactured with low-absorption plastics to avoid partial absorption of the components of the infused solutions. It typically consists of plastic tubes made of or lined with non absorbing plastics [e.g., polyethylene (PE), Teflon], to avoid solution contact with polyvinyl chloride (PVC) components; it also includes a check valve, a roller clamp, a Y-site connector, and Luer adaptors. The set is mainly used in high-flow infusion pumps for administration of solutions containing products (e.g., nitroglycerin) that are absorbed by PVC materials. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)248-4058CUSTOMERSERVICE@CENTURIONMP.COM

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

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00653160274882CenturionPE31802018-02-11
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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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00813153028124FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028131FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028148FRESENIUS KABICodan US CorporationFPA2026-02-05
00813153028155FRESENIUS KABICodan US CorporationFPA2026-02-05
B2125720502Male Luer Slip PlugINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700B2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700G2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700R2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700V2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
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10801741239189PowerLocBard Access Systems, Inc.FPA2026-01-20
10801741239196MiniLocBard Access Systems, Inc.FPA2026-01-20
10801741239202MiniLocBard Access Systems, Inc.FPA2026-01-20
10817708023418OPTFlowEMED TECHNOLOGIES CORPORATIONFPA2026-01-09
23661657080947NEUTRACLEAR BIDIRECTIONAL VALVE WITH PROTECTIVE CAPCAIR LGLFPA2026-01-01
2366165708095413,5 CM PE/PVC EXTENSION TUBING WITH 1 NEUTRACLEAR + 1 CLAMP + 1 MOBILE RINGCAIR LGLFPA2026-01-01