FDA.reportPublic FDA data

AMSure® Urine Meter Drainage Bag

Primary DI
10704411005490
Brand
AMSure® Urine Meter Drainage Bag
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
AS327200
Device description
AMSure® Urine Meter Drainage BagCONTENTS:200cc Blow Molded Urine Meter with 2000mL Drainage Bag
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFGDevice, Urine Flow Rate Measuring, Non-Electrical, DisposableGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411005491PackageGS110In Commercial Distribution
10704411005490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441100549140704411005491
1070441100549010704411005490

GMDN Terms#

Term, Definition table
TermDefinition
Urine flowmeter, single-useA non-electrical device that is used to measure the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder. This device is a single-use device. This GMDN code may reflect old technology.

Regulatory Flags#

DUNS number
825673239
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
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20197344157881MEDLINEMEDLINE INDUSTRIES, INC.FFG2025-08-05
10192253028423DoverCardinal Health 200, LLCFFG2025-04-01
50192253028421DoverCardinal Health 200, LLCFFG2025-04-01
10192253028980DoverCardinal Health 200, LLCFFG2025-01-15
50192253028988DoverCardinal Health 200, LLCFFG2025-01-15
10888277678415MedlineMEDLINE INDUSTRIES, INC.FFG2021-09-16
20888277678412MedlineMEDLINE INDUSTRIES, INC.FFG2021-09-16
10888277678392MedlineMEDLINE INDUSTRIES, INC.FFG2021-01-05
20888277678399MedlineMEDLINE INDUSTRIES, INC.FFG2021-01-05
10080196998401MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
10884389121191MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
40080196998402MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
40884389121192MedlineMEDLINE INDUSTRIES, INC.FFG2020-12-23
10704411013075AMSure® Urine Meter Drainage BagAMSINO INTERNATIONAL, INC.FFG2020-10-16
40704411013076AMSure® Urine Meter Drainage BagAMSINO INTERNATIONAL, INC.FFG2020-10-16
00801741019357Bard® CritiCore® Collection ContainerC. R. Bard, Inc.FFG2017-03-22
10801741019354Bard® CritiCore® Collection ContainerC. R. Bard, Inc.FFG2017-03-22
10080196749577MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
10884389119495MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
10888277136946MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
40888277136947MedlineMEDLINE INDUSTRIES, INC.FFG2016-10-14
10884521029583DoverCardinal Health 200, LLCFFG2016-09-28
20884521029580DoverCardinal Health, Inc.FFG2016-09-28
10884521002180DoverCardinal Health 200, LLCFFG2016-09-24
10884521004498DoverCardinal Health, Inc.FFG2016-09-24
10884521004511DoverCardinal Health, Inc.FFG2016-09-24
10884521029620DoverCardinal Health 200, LLCFFG2016-09-24