FDA.reportPublic FDA data

Foley Catheters

Primary DI
00616784497037
Brand
Foley Catheters
Company
DYNAREX CORPORATION
Model
4970
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00616784497037PackageGS110In Commercial Distribution
00616784497020PrimaryGS10
00616784497013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784497037006167844970376167844970370616784497037
00616784497020006167844970206167844970200616784497020
00616784497013006167844970136167844970130616784497013

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
008124539
Device count
10
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

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Primary DI, Brand, Company table
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50192253068229DoverCardinal Health 200, LLCEZL2026-01-15
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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
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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