FDA.reportPublic FDA data

Acosta Uro-Gard

Primary DI
00860012266807
Brand
Acosta Uro-Gard
Company
Acosta Medical Group, Inc.
Model
90-2003-001
Catalog number
90-2003-001
Device description
Uro-Gard Urinary Collection Bag
Published
2025-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NNWBag, Urine Collection, Leg, For External Use, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012266807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012266807008600122668078600122668070860012266807

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081186149
Device count
1
Premarket exempt
true
Kit
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860012266811Acosta Uro-Gard90-2003-00290-2003-0022025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860012266811Acosta Uro-GardAcosta Medical Group, Inc.NNW2025-02-19
10618125191182TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
00618125191185TIDIShieldTIDI PRODUCTS, LLCNNW2024-04-05
15060797553860NADavid Scott CompanyNNW2023-07-26
00615521015336ALLENHILL-ROM, INC.NNW2023-05-26
00615521015350ALLENHILL-ROM, INC.NNW2023-05-26
00615521015367ALLENHILL-ROM, INC.NNW2023-05-26
00615521019990ALLENHILL-ROM, INC.NNW2023-05-26
00615521020002ALLENHILL-ROM, INC.NNW2023-05-26
00615521020019ALLENHILL-ROM, INC.NNW2023-05-26
00615521020606ALLENHILL-ROM, INC.NNW2023-05-26
00615521020675ALLENHILL-ROM, INC.NNW2023-05-26
05708932135184ConveenColoplast A/SNNW2023-01-17
00762123017197ConveenColoplast A/SNNW2023-01-17
15060797553600NADavid Scott CompanyNNW2023-01-09
10810087350489CoulmedCoulmed Products Group LLCNNW2023-01-06
10810087350502CoulmedCoulmed Products Group LLCNNW2023-01-06
00762123032282ColoplastColoplast A/SNNW2022-12-05
00762123032299ColoplastColoplast A/SNNW2022-12-05
05708932640312ConveenColoplast A/SNNW2022-12-02
05708932732420Conveen StandardColoplast A/SNNW2022-12-02
05708932640329ConveenColoplast A/SNNW2022-12-02
00762123002094Conveen StandardColoplast A/SNNW2022-12-02
00610075093427HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093434HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093489HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093496HollisterHOLLISTER INCORPORATEDNNW2022-12-01
20610075093421HollisterHOLLISTER INCORPORATEDNNW2022-12-01
20610075093438HollisterHOLLISTER INCORPORATEDNNW2022-12-01
20610075093452HollisterHOLLISTER INCORPORATEDNNW2022-12-01