FDA.reportPublic FDA data

Uro-Kit® Reusable Latex Leg Bag System 18 oz.

Primary DI
00792293985187
Brand
Uro-Kit® Reusable Latex Leg Bag System 18 oz.
Company
UROCARE PRODUCTS, INC.
Model
98518
Catalog number
98518
Device description
BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, MEDIUM, 18 FL. OZ. (550 ML.) CONTENTS: 1 Reusable Latex Urinary Leg Bag #8518, 1 Fabric Sport Bag Strap #6350, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adapter with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
Published
2018-04-10
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293985187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293985187007922939851877922939851870792293985187

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
Total Volume18Fluid Ounce

Sterilization Methods#

Method table
Method

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
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm5301245301242025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm5301285301282025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm5301315301312025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm5301355301352025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm5301405301402025-01-01
00792293781802Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78180781802020-07-30
00792293781819Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78181781812020-07-30
00792293783202Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78320783202020-07-30
00792293783219Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78321783212020-07-30
00792293791801Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79180791802020-07-30
00792293791818Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79181791812020-07-30
00792293793201Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79320793202020-07-30
00792293793218Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79321793212020-07-30
10792293042009Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)420042002018-04-10
10792293060096Urocare® Tubing Connector, Small 0.31" OD x 2.25"600960092018-06-01
10792293060102Urocare® Tubing Connector, Large 0.38" OD x 2.25"601060102018-06-01
10792293060133Urocare® Catheter Connector, Small 0.31" OD x 3"601360132018-05-31
10792293060140Urocare® Catheter Connector, Large 0.38" OD x 3"601460142018-05-31
10792293060164Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
10792293060171Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31

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50192253028520DoverCardinal Health 200, LLCKNX2024-12-20
50192253028537DoverCardinal Health 200, LLCKNX2024-12-20
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