FDA.reportPublic FDA data

AMSure® PVC Intermittent Catheter

Primary DI
40704411003640
Brand
AMSure® PVC Intermittent Catheter
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
AS860614
Device description
AMSure® PVC Intermittent Catheter Female 6" Length
Published
2016-09-23
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

Product Codes#

Code, Name table
CodeName
EZDCatheter, Straight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411003640PackageGS150In Commercial Distribution
10704411003649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441100364040704411003640
1070441100364910704411003649

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral drainage catheter, reusableA flexible or rigid tube designed to be repeatedly inserted through the urethra, typically by the user (i.e., self-applied), to the urinary bladder to provide short-term, episodic urine drainage (removed after each void), typically for an individual who is physiologically incapable of voiding. Because of the potential frequency of catheterization, the device will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) - Teflon, or glass]. The device may be male or female dedicated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825673239
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
10704411017080AMSure ® Hydrophilic Latex Foley Catheters1AS41012HC2026-05-15
10704411017097AMSure ® Hydrophilic Latex Foley Catheters1AS41014HC2026-05-15
10704411017103AMSure ® Hydrophilic Latex Foley Catheters1AS41016HC2026-05-15
10704411017110AMSure ® Hydrophilic Latex Foley Catheters1AS41018HC2026-05-15
10704411017127AMSure ® Hydrophilic Latex Foley Catheters1AS41020HC2026-05-15
10704411017134AMSure ® Hydrophilic Latex Foley Catheters1AS41022HC2026-05-15
10704411017141AMSure ® Hydrophilic Latex Foley Catheters1AS41024HC2026-05-15
10704411017158AMSure ® Hydrophilic Latex Foley Catheters1AS42016HC2026-05-15
10704411017165AMSure ® Hydrophilic Latex Foley Catheters1AS42018HC2026-05-15
10704411017172AMSure ® Hydrophilic Latex Foley Catheters1AS42020HC2026-05-15
10704411017189AMSure ® Hydrophilic Latex Foley Catheters1AS42022HC2026-05-15
10704411017196AMSure ® Hydrophilic Latex Foley Catheters1AS42024HC2026-05-15
10704411021544AMSure® Cystoscopy/Bladder Irrigation Set1ABL4002026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation Set1ABL4042026-04-10
10704411018834AMSure ® SUTURE REMOVAL KIT1SRT0012026-04-03
10704411018841AMSure ® Suture Removal Kit1SRT0022026-04-03
10704411018858AMSure ® Suture Removal Kit1SRT001Z2026-04-03
40704411007464AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS35302026-04-03
40704411007471AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10102026-04-03
40704411007488AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10032026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344162031MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-20
10197344162178MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-10-14
10197344162024MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162048MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162055MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162062MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162079MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162116MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162123MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162130MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162147MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162154MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162161MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162185MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162192MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162208MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162215MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162222MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162239MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162246MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162253MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162260MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162277MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
10704411008828AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008835AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008842AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008859AMSure ® HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008873AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02
10704411008880AMSure®HG Hydrophilic Intermittent Urethral CatheterAMSINO INTERNATIONAL, INC.EZD2025-07-02