AMSure® Urethral Self Catheterization Kit 10Fr. AS85010K

GUDID 40704411007563

AMSure® Urethral Self Catheterization Kit 10Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad

AMSINO INTERNATIONAL, INC.

Intermittent urethral catheterization kit

• Primary Device ID: 40704411007563
• NIH Device Record Key: e1411dfd-8da7-47fb-91ca-294cfef47295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Urethral Self Catheterization Kit 10Fr.
• Version Model Number: 1
• Catalog Number: AS85010K
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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	10704411007562 [Primary]
GS1	40704411007563 [Package]; Contains: 10704411007562; Package: case [50 Units]; In Commercial Distribution

FDA Product Code

• FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-28
• Device Publish Date: 2018-04-28

Devices Manufactured by AMSINO INTERNATIONAL, INC.

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• 40704411016626 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 3mL, use only in flushing compatible intravenous administ
• 40704411016633 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 5mL, use only in flushing compatible intravenous administ
• 40704411016640 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 10mL, use only in flushing compatible intravenous adminis
• 40704411016244 - AMSafe ® I.V Administration Set 100'': 2023-08-28 For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.5m), 10 drops/mL, Slide and Roller Clamp, 1.2 Micron Filter
• 40704411016152 - AMSure ® Enteral Administration Kit: 2023-06-01 Enteral Administration Kit FOR USE WITH AMSure® ENTERAL FEEDING PUMP CONTENTS: -Enteral Feeding 500 mL Bag Pump Set with ENFit