FDA.reportPublic FDA data

CENTURION

Primary DI
20653160251610
Brand
CENTURION
Company
CENTURION MEDICAL PRODUCTS CORPORATION
Model
FCS300XT
Catalog number
FCS300XT
Device description
FOLEY CATHETER SECUREMENT PE FOAM 1/32"
Published
2022-01-01
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

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
10653160251613PackageGS150In Commercial Distribution
20653160251610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065316025161310653160251613
2065316025161020653160251610

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holder, single-useA device designed to be attached to a patient's body to hold an indwelling urinary catheter line (typically Foley) in place. It consists of a wrap or adhesive strip/pad, e.g., placed around the patient's thigh. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip). It is not designed to hold a urine collection bag. 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
10653160286844CENTURIONI67350I673502022-01-01
10653160349006CENTURION67850678502021-11-29
00653160022360CENTURION66360663602021-12-31
10653160395225CENTURIONIVS4231IVS42312026-10-14
10653160395256CENTURIONIVS3945BIVS3945B2026-10-14
10653160395355CENTURIONCIT3065BCIT3065B2026-10-14
10653160395232CENTURIONCIT6750ACIT6750A2026-10-13
10653160393443CENTURIONDT23110DT231102026-10-08
10653160394075CENTURIONDT21660CDT21660C2026-10-08
10653160393344CENTURIONDM1348DM13482026-10-07
10653160393818CENTURIONDT15200CDT15200C2026-10-07
10653160394464CENTURIONDT12565ADT12565A2026-10-07
10653160320265CENTURIONID1945AID1945A2022-01-01
10653160365815CENTURIONI69005I690052023-09-05
00653160013191CENTURIONHT855HT8552017-08-25
10653160393450CENTURIONCVI5404CVI54042026-10-05
10653160394242CENTURIONCIT7621CIT76212026-10-05
10653160394297CENTURIONCHT1885ACHT1885A2026-10-05
10653160394570CENTURIONCIT2285ACIT2285A2026-10-05
10653160394754CENTURIONCIT5165ACIT5165A2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394433MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394457MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394556MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394587MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394662MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394679MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394693MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394907MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395072MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395096MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395102MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395218MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395300MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395362MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395379MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395454MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395515MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395522MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395546MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395560MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14
10653160395638MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-14