Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.) 99516

GUDID 00792293995162

BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-RIGHT LARGE, 16 FL. OZ. (500 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9516, 1 Fabric Sport Bag Strap #6342, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.

UROCARE PRODUCTS, INC.

Open-ended wearable urine collection bag, non-sterile

• Primary Device ID: 00792293995162
• NIH Device Record Key: b6e6b7df-1ba6-4f5f-b8b9-b91f81982776
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.)
• Version Model Number: 99516
• Catalog Number: 99516
• 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: true
• 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

• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound
• Weight: 1.78 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792293995162 [Primary]

FDA Product Code

• MDZ: Cleaners, Medical Devices

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: 2018-04-09

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