FDA.reportPublic FDA data

Centurion

Primary DI
00653160353631
Brand
Centurion
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
DT21340B
Catalog number
DT21340B
Device description
PEDIATRIC PORT ACCESS SYSTEM-INPATIE
Published
2022-06-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRSI.V. start kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160353631PackageGS124In Commercial Distribution
10653160353638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160353631006531603536316531603536310653160353631
1065316035363810653160353638

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160241010CenturionHGL30HGL302022-01-01
10653160246305CenturionIVS1515IVS15152022-01-01
10653160246589CenturionSV733UDTSV733UDT2022-01-02
10653160250005CenturionHG440XTHG440XT2022-01-01
10653160250234CenturionFCS300FCS3002022-01-01
10653160258063CenturionIV690IV6902022-01-01
10653160262756CenturionANCPR320STANCPR320ST2022-01-01
10653160267270CenturionSV430AFXTSV430AFXT2022-01-02
10653160267294CenturionSV733AFXTSV733AFXT2022-01-02
10653160270164CenturionANC32XT-6ANC32XT-62022-01-01
10653160270171CenturionANC52XT-6ANC52XT-62022-01-01
10653160270201CenturionSCVP44XT-6SCVP44XT-62022-01-02
10653160270218CenturionSCVP66XT-6SCVP66XT-62022-01-02
10653160270256CenturionSV44UXT2-6SV44UXT2-62022-01-02
10653160270263CenturionSV60NXT-6SV60NXT-62022-01-02
10653160270348CenturionSV46VST-6SV46VST-62022-01-02
10653160270386CenturionSV48NFST-6SV48NFST-62022-01-02
10653160270393CenturionSV48VXT-6SV48VXT-62022-01-02
10653160270409CenturionSV80FST-6SV80FST-62022-01-02
10653160270775CenturionSV65NXTSV65NXT2022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09555240405210IV Start KitITL ASIA PACIFIC SDN. BHD.LRS2023-06-28
10193489112672MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-10-25
10193489111880MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-10-01
10193489111811MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-24
10193489111781MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-17
10193489111668MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-03
10193489111675MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-03
10193489111606MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-30
10193489111217OTHERMEDLINE INDUSTRIES, INC.LRS2021-08-27
10193489111545MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-20
10193489111552MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-20
10193489111385MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489111422MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489111446MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489110876MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-13
10193489111057MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-13
10193489110883MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110890MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110906MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110913MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110999MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110838MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-28
10193489110807MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-21
10193489110678MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-20
10193489110708MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-14
10193489110722MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-14
10193489110739MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-14
10193489110647MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-09
10193489110487MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-05-24
10193489110555MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-05-24