Urocare® Reusable Latex Leg Bag 16 oz. (500 mL.) 8516

GUDID 00792293085160

BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-LEFT LARGE, 16 FL. OZ. (500 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions.

UROCARE PRODUCTS, INC.

Open-ended wearable urine collection bag, non-sterile

• Primary Device ID: 00792293085160
• NIH Device Record Key: 5e4abc94-3cac-459a-98da-5fb60d7d1695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urocare® Reusable Latex Leg Bag 16 oz. (500 mL.)
• Version Model Number: 8516
• Catalog Number: 8516
• Company DUNS: 070637129
• Company Name: UROCARE PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM

Device Dimensions

• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch
• Depth: 1 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792293085160 [Primary]

FDA Product Code

• NNW: Bag, Urine Collection, Leg, For External Use, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-06

On-Brand Devices [Urocare® Reusable Latex Leg Bag 16 oz. (500 mL.)]

• 00792293095169: BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-RIGHT LARGE, 16 FL. OZ.
• 00792293085160: BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-LEFT LARGE, 16 FL. OZ.