FDA.reportPublic FDA data

AMSure® PVC Intermittent Catheter

Primary DI
40704411003732
Brand
AMSure® PVC Intermittent Catheter
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
AS861612
Device description
AMSure® PVC Intermittent Catheter Male 16" 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
40704411003732PackageGS150In Commercial Distribution
10704411003731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441100373240704411003732
1070441100373110704411003731

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
40704411021088AMSafe® I.V. Administration Set11010802B2025-12-29
40704411020241AMSure® 0.9% Sodium Chloride lrrigation USP 100 mL, Sterile1AS-62402025-12-05
40704411020258AMSure® Sterile Water for lrrigation USP 100 mL1AS-62502025-12-05
00704411020267AMSure® Sterile Water for lrrigation USP 250 mL1AS-62602025-12-05
40704411020272AMSure® 0.9% Sodium Chloride lrrigation USP 250 mL, Sterile1AS-62702025-12-05
40704411020500AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile1AS-63802025-12-05
40704411020517AMSure® Sterile Water for lrrigation USP 500 mL1AS-63902025-12-05
40704411020524AMSure® 0.9% Sodium Chloride lrrigation USP 1000 mL, Sterile1AS-64812025-12-05
40704411020531AMSure® Sterile Water for lrrigation USP 1000 mL1AS-64912025-12-05
40704411008829AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716102025-07-02
40704411008836AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716122025-07-02
40704411008843AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716142025-07-02
40704411008850AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716162025-07-02
10704411008866AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971610SS2025-07-02
40704411008874AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971612SS2025-07-02
40704411008881AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971614SS2025-07-02
40704411008898AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971616SS2025-07-02
40704411019542AMSure® Foley Catheter Tray1AS894142025-07-01
40704411019559AMSure® Foley Catheter Tray1AS894162025-07-01
40704411019566AMSure® Foley Catheter Tray1AS894182025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50850058254451EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
00850058254463EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254475EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254482EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254499EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254505EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254512EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254529EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254536EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254543EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254550EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
50850058254567EZ-Protect™HR PHARMACEUTICALS INC.EZD2026-02-05
05708932778275SpeediCath Flex SetColoplast A/SEZD2026-02-05
05708932778282SpeediCath Flex SetColoplast A/SEZD2026-02-05
07333387054537LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054575LoFric® Origo™Wellspect ABEZD2025-11-24
07333387054605LoFric® Origo™Wellspect ABEZD2025-11-24
20197344162021MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162045MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162052MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162069MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162076MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162113MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162120MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162137MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162144MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162151MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162168MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162182MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22
20197344162199MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22