FDA.reportPublic FDA data

CENTURION

Primary DI
10653160393450
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
CVI5404
Catalog number
CVI5404
Device description
MCLAREN PORT PACK
Published
2026-10-05
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
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160393453PackageGS125In Commercial Distribution
10653160393450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160393453006531603934536531603934530653160393453
1065316039345010653160393450

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
017246562
Device count
1
DM exempt
false
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
10653160394242CENTURIONCIT7621CIT76212026-10-05
10653160394297CENTURIONCHT1885ACHT1885A2026-10-05
10653160394570CENTURIONCIT2285ACIT2285A2026-10-05
10653160394754CENTURIONCIT5165ACIT5165A2026-10-05
10653160394785CENTURIONCIT5350ACIT5350A2026-10-05
10653160394808CENTURIONCIT4660ACIT4660A2026-10-05
10653160328131CENTURIONDT22125DT221252022-01-01
10653160353461CENTURIONDT21830BDT21830B2022-05-31
10653160381341CENTURIONDM1336DM13362024-10-07
10653160323082CENTURIONCHT1730CHT17302022-01-01
10653160341222CENTURIONCMPSN001ACMPSN001A2020-01-27
00653160005301CENTURION75121751212022-01-01
00653160081756CENTURION66965669652021-12-31
10653160251729CENTURIONMNS7810MNS78102022-01-01
10653160254799CENTURIONCHT890CHT8902022-01-01
10653160257028CENTURIONSUT18270SUT182702022-01-02
10653160257417CENTURIONCIT5460CIT54602016-09-05
10653160279068CENTURIONSUT19360SUT193602022-01-02
10653160291060CENTURIONMNS9970MNS99702022-01-02
10653160292029CENTURIONMNS9715MNS97152022-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570979CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10198956586239CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10198956588097CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10198956589766CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-06
10198956531673CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-30
10198956583771CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-30
10198956566088CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956571143CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956580428CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956587120CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956566644CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956568280CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956578357CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956581654CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956586178CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956580268CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-22
10198956562271CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956573550CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956584426CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10653160394389MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394419MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394525MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394648MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394761MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394891MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394990MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160395140MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10198956538856CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956539617CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956556744CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04