FDA.report

AMSure® Urinary Leg Bag with Extension Tube

Primary DI
40704411006283
Brand
AMSure® Urinary Leg Bag with Extension Tube
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
LBE309N
Device description
AMSure® Urinary Leg Bag with Extension Tube Large - 900 mL, Twist Valve
Published
2017-07-01
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

Related Records

Product Codes

CodeName
FAQBag, Urine Collection, Leg, For External Use, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
FAQBag, Urine Collection, Leg, For External Use, SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40704411006283PackageGS148In Commercial Distribution
10704411006282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4070441100628340704411006283
1070441100628210704411006282

GMDN Terms

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

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

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40704411020258AMSure® Sterile Water for lrrigation USP 100 mL1AS-62502025-12-05
00704411020267AMSure® Sterile Water for lrrigation USP 250 mL1AS-62602025-12-05
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40704411020531AMSure® Sterile Water for lrrigation USP 1000 mL1AS-64912025-12-05
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40704411019559AMSure® Foley Catheter Tray1AS894162025-07-01
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