UNBRANDED

GUDID 10848340002097

UroView System Pack

ADVANCE MEDICAL DESIGNS, INC.

Extracorporeal circuit waste bag, sterile

• Primary Device ID: 10848340002097
• NIH Device Record Key: 15cd505f-f09b-4f2d-9b2f-442aa46db730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNBRANDED
• Version Model Number: 07-PK805
• Company DUNS: 130785884
• Company Name: ADVANCE MEDICAL DESIGNS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848340002090 [Primary]
GS1	10848340002097 [Package]; Contains: 00848340002090; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012168

FDA Product Code

• KKX: Drape, surgical

Sterilization

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

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

[10848340002097]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [UNBRANDED]

• 10848340010771: Urologic Drain Bag
• 10848340010764: Urologic Drain Bag
• 10848340010757: Urologic Drain Bag
• 10848340010740: Urologic Drain Bag
• 10848340010221: C-Arm
• 10848340010207: Snap Kover
• 10848340009980: Snap Kap
• 10848340009973: Snap Kover
• 10848340009775: C-Arm
• 10848340009768: Set-up Cover
• 10848340009751: Knob Cover
• 10848340009744: Micro Kover
• 10848340009737: Micro Kover
• 10848340009713: Snap Kap
• 10848340009706: Snap Kap
• 10848340009690: Snap Kap
• 10848340009683: Snap Kap
• 10848340009669: Camera Cover
• 10848340009652: Camera Cover
• 10848340009645: Camera Cover
• 10848340009614: Snap Kover
• 10848340009607: Snap Kover
• 10848340009591: Snap Kover
• 10848340009584: Snap Kover
• 10848340009577: Snap Kover
• 10848340009560: Snap Kover
• 10848340009553: Pressure Monitoring line
• 10848340009546: Probe Cover
• 10848340009539: Light Handle Cover
• 10848340009522: Light Handle Cover
• 10848340009515: Light Handle Cover
• 10848340009508: Urologic Drain Bag
• 10848340009492: Urologic Drain Bag
• 10848340009485: Urologic Drain Bag
• 10848340009478: Urologic Drain Bag
• 10848340009454: Light Handle Cover
• 10848340009447: Light Handle Cover
• 10848340009430: Urologic Drain Bag
• 10848340009423: Urologic Drain Bag
• 10848340009416: Urologic Drain Bag
• 10848340009409: Urologic Drain Bag
• 10848340009393: Prove Cover
• 10848340009386: Prove Cover
• 10848340009379: UroView System Pack
• 10848340009362: Arterial Needle
• 10848340009355: Arterial Needle
• 10848340009331: Arterial Needle
• 10848340009324: Prove Cover
• 10848340009317: Light Handle Cover
• 10848340009300: Prove Cover