FDA.reportPublic FDA data

Urocare® Gasket Ring, Large (Set of 10)

Primary DI
00792293060006
Brand
Urocare® Gasket Ring, Large (Set of 10)
Company
UROCARE PRODUCTS, INC.
Model
6000
Catalog number
6000
Device description
GASKET RING, VALVE, URINE COLLECTION, LARGE, REUSABLE, REPLACEMENT, SET OF 10 Replacement Gasket-Ring for: Urinary Drainage Bottle 2,000 mL. #4100, Urinary Drainage Bottle 4,000 mL. #4140 and Anti-Reflux Valve #6001 found in all Urocare Latex Urinary Leg Bags.
Published
2018-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter
NNWBag, Urine Collection, Leg, For External Use, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293060006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293060006007922930600067922930600060792293060006

GMDN Terms#

Term, Definition table
TermDefinition
Open-ended wearable urine collection bag, non-sterileA non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Outer Diameter0
Weight0

Contacts#

Phone, Email table
PhoneEmail
909-621-6013CUST.SUPPORT@UROCARE.COM

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293041005Urocare® Reusable Urinary Drainage Bottle 2,000 mL.410041002018-04-11
00792293041012Urocare® Cap with Housing for Reusable Urinary Drainage Bottle410141012018-04-11
00792293041029Urocare® Hooks for Reusable Urinary Drainage Bottle410241022018-04-11
00792293060013Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve)600160012018-04-11
00792293060037Urocare® Top Adapter for Urinary Drainage Bottle600360032018-04-11
00792293060167Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
00792293060174Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31
00792293060181Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18"601860182018-05-31
00792293060198Urocare® Tubing Clear-Vinyl with Connector 0.31" x 18"601960192018-05-31
00792293060617Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606160612018-04-11
00792293060860Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18"608660862018-05-31
00792293069993Urocare® Thumb Tube Clamp, Adjustable699969992018-04-11
00792293070005Urocare® Thumb Tube Clamp, Two-Position700070002018-04-11
00792293070036Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm)700370032018-06-01
00792293702043Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.)7002047002042018-06-01
00792293702166Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.)7002167002162018-06-01
00792293041401Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)414041402018-04-11
00792293060204Urocare® Tubing Clear-Vinyl with Connector and Sterile 0.31" x 18"602060202018-05-31
00792293060600Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606060602018-04-11
00792293060853Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 8.5"608560852018-05-31

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