FDA.reportPublic FDA data

McKesson

Primary DI
40612479245202
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-SFOL3020
Device description
CATHETER, FOLEY STRAIGHT TIP SILICONE 16" 20FR 15-30CC
Published
2020-01-06
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

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479245192PackageGS110In Commercial Distribution
40612479245202PackageGS120In Commercial Distribution
10612479245188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247924519220612479245192
4061247924520240612479245202
1061247924518810612479245188

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253068229DoverCardinal Health 200, LLCEZL2026-01-15
50192253068236DoverCardinal Health 200, LLCEZL2026-01-15
50192253067659DoverCardinal Health 200, LLCEZL2025-04-14
20192253067665DoverCardinal Health 200, LLCEZL2025-04-14
50192253067673DoverCardinal Health 200, LLCEZL2025-04-14
20192253067689DoverCardinal Health 200, LLCEZL2025-04-14
20884522000014Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000024Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000031Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000048Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000055Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
10884522000062Covidien AGDEGANIA SILICONE LTDEZL2025-04-03
00850029182016Egress Safety CatheterInnoCare Urologics, LLCEZL2025-03-19
27290110066516Covidien AGDEGANIA SILICONE LTDEZL2025-03-04
27290110066479Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066486Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066493Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066509Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
27290110066523Covidien AGDEGANIA SILICONE LTDEZL2025-02-20
16936881165051All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785653All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785684All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785714All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785752All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785790All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785820All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785844All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785875All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785882All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05
16944932785912All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co.,LtdEZL2025-02-05