FDA.report

Centurion

Primary DI
00653160237481
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
DT14475
Catalog number
DT14475
Device description
DIALYSIS ON/OFF KIT
Published
2022-01-01
Public version status
New
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
FKGTRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Product Code Classifications

CodeDeviceSpecialtyClass
FKGTray, Start/Stop (Including Contents), DialysisGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653160237481PackageGS125In Commercial Distribution
10653160237488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160237481006531602374816531602374810653160237481
1065316023748810653160237488

GMDN Terms

TermDefinition
Haemodialysis start/stop setA collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(517)546-5400CUSTOMERSERVICE@CENTURIONMP.COM

Regulatory Flags

DUNS number
017246562
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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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Other Devices Sharing Product Codes

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50198956094725CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
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00653160375176MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
50197106349869CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
00653160361001MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
50197106092451CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
00653160359633MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
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50197106200290CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
50197106212651CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
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50197106198429CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-30
50197106174294CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-29
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50197106043323CARDINAL HEALTHCardinal Health 200, LLCFKG2022-12-05
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50195594756831CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
50195594758521CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
50195594767189CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29