AMSure® Urine Meter Drainage Bag AS328

GUDID 40704411013076

AMSure® Urine Meter Drainage Bag Contents: 400 cc Urine Meter with 2600 ml Drainage Bag Caution: Avoid freezing and excessive heat.

AMSINO INTERNATIONAL, INC.

Urine flowmeter, single-use

• Primary Device ID: 40704411013076
• NIH Device Record Key: 6b3588f3-0da0-4e04-a229-5ea91caf9964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Urine Meter Drainage Bag
• Version Model Number: 1
• Catalog Number: AS328
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411013075 [Primary]
GS1	40704411013076 [Package]; Contains: 10704411013075; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• FFG: Device, Urine Flow Rate Measuring, Non-Electrical, Disposable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-10-16

Devices Manufactured by AMSINO INTERNATIONAL, INC.

• 40704411008829 - AMSure ® HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 10Fr
• 40704411008836 - AMSure ® HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 12Fr
• 40704411008843 - AMSure ® HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 14Fr
• 40704411008850 - AMSure ® HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 16Fr
• 10704411008866 - AMSure®HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 10Fr
• 40704411008874 - AMSure®HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 12Fr
• 40704411008881 - AMSure®HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 14Fr
• 40704411008898 - AMSure®HG Hydrophilic Intermittent Urethral Catheter: 2025-07-10 AMSure ® HG Hydrophilic Intermittent Urethral Catheter with water sachet and sleeve 16Fr