FDA.reportPublic FDA data

AMSure® Urinary Leg Bag

Primary DI
40704411008287
Brand
AMSure® Urinary Leg Bag
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
AS309F
Device description
AMSure® Urinary Leg Bag Large - 900 mL, Flip Valve CONTENTS: One each 900 mL leg bag equipped with: Flip valve drainage outlet Anti-reflux valve Two latex-free straps
Published
2018-05-30
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
FAQBag, Urine Collection, Leg, For External Use, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAQBag, Urine Collection, Leg, For External Use, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411008287PackageGS148In Commercial Distribution
10704411008286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441100828740704411008287
1070441100828610704411008286

GMDN Terms#

Term, Definition table
TermDefinition
Wearable urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825673239
Device count
1
DM exempt
false
Premarket exempt
true
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
04046961018650ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCFAQ2026-03-16
00850063139496Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139502Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139519Neil Medical Group Neil Medical GroupFAQ2025-12-08
00850063139526Neil Medical Group Neil Medical GroupFAQ2025-12-08
26975424198269Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198283Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198306Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198320Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198344Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198368Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
26975424198382Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.FAQ2025-12-03
16974500612555Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612562Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
16974500612579Disposable Urinary Leg BagGCMEDICA ENTERPRISE LTD.(WUXI)FAQ2025-08-07
10661392002248LSL HEALTHCARELSL Industries, LLCFAQ2025-05-16
00810113579757ViveVIVE HEALTH LLCFAQ2025-04-07
10810113579761ViveVIVE HEALTH LLCFAQ2025-04-07
10810113579976ViveVIVE HEALTH LLCFAQ2025-04-07
10810113579983ViveVIVE HEALTH LLCFAQ2025-04-07
50192253028643DoverCardinal Health 200, LLCFAQ2025-04-04
50192253028650DoverCardinal Health 200, LLCFAQ2025-04-04
50192253028667DoverCardinal Health 200, LLCFAQ2025-04-04
07333387044088GentleCathTMOASIS MEDIKAL URUNLER KIMYA TURIZM SANAYI VE TICARET ANONIM SIRKETIFAQ2024-06-01
07333387043869SimPro™ SetWellspect ABFAQ2024-05-02
07333387043500SimPro™ SetWellspect ABFAQ2024-05-01
00840118617871ENDURE INDUSTRIESENDURE INDUSTRIESFAQ2024-04-17
05055788765332FlexicareFLEXICARE MEDICAL LIMITEDFAQ2024-03-05
05055788765486FlexicareFLEXICARE MEDICAL LIMITEDFAQ2024-03-05
05055788766308FlexicareFLEXICARE MEDICAL LIMITEDFAQ2024-03-05