iReceptal™ Disposable Manifold iRM400-01

GUDID 00704411011234

iReceptal™ Disposable Manifold

AMSINO INTERNATIONAL, INC.

Suction system canister liner

• Primary Device ID: 00704411011234
• NIH Device Record Key: 892da329-228a-4980-99f2-cf4e72ddda25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iReceptal™ Disposable Manifold
• Version Model Number: 1
• Catalog Number: iRM400-01
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 10
• 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	00704411011234 [Unit of Use]
GS1	40704411011232 [Primary]

FDA Product Code

• GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-30
• Device Publish Date: 2020-03-20

Devices Manufactured by AMSINO INTERNATIONAL, INC.

• 40704411021088 - AMSafe® I.V. Administration Set: 2026-01-06 108" (274 cm) Long Approximately 10 Drops/mL Y Injection Site Rotating Male Luer Lock Adapter
• 40704411020241 - AMSure® 0.9% Sodium Chloride lrrigation USP 100 mL, Sterile: 2025-12-15
• 40704411020258 - AMSure® Sterile Water for lrrigation USP 100 mL: 2025-12-15
• 00704411020267 - AMSure® Sterile Water for lrrigation USP 250 mL: 2025-12-15
• 40704411020272 - AMSure® 0.9% Sodium Chloride lrrigation USP 250 mL, Sterile: 2025-12-15
• 40704411020500 - AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile: 2025-12-15
• 40704411020517 - AMSure® Sterile Water for lrrigation USP 500 mL: 2025-12-15
• 40704411020524 - AMSure® 0.9% Sodium Chloride lrrigation USP 1000 mL, Sterile: 2025-12-15