FDA.reportPublic FDA data

Foley Catheters

Primary DI
00616784496634
Brand
Foley Catheters
Company
DYNAREX CORPORATION
Model
4966
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
00616784496634PackageGS110In Commercial Distribution
00616784496627PrimaryGS10
00616784496610Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784496634006167844966346167844966340616784496634
00616784496627006167844966276167844966270616784496627
00616784496610006167844966106167844966100616784496610

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
00840117343764Dynacare Necessities Complete Kit13742026-05-28
00616784812137Drape Sheets, Tissue 2-ply, White, 40" x 48"81212021-09-01
00616784812236Drape Sheets81222021-09-01
00616784812335Drape Sheets81232021-09-01
00616784813134Drape Sheets, Tissue 2-ply, White, 40" x 60"81312021-09-01
00616784813233Drape Sheets81322021-09-01
00616784813332Drape Sheets81332021-09-01
00616784814131Drape Sheets, Tissue 2-ply, White81412021-09-01
00616784815039Drape Sheets, Tissue 2-ply, Blue, 40" x 90"81502021-09-01
00616784815138Drape Sheets, Tissue 2-Ply, white, 40" x 90"81512021-09-01
00616784816135Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White81612021-09-01
00616784890128SecureSafe Safety Insulin Syringe89012017-10-16
00616784890425SecureSafe Safety Insulin Syringe89042017-10-16
00616784892825SecureSafe Syringes With Safety Needle, Non-Toxic, 3 ML, Luer Lock89282017-10-16
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04
10192253066340DoverCardinal Health 200, LLCEZL2024-09-04