N/A

GUDID 46975124930071

Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic Vial/bottle adaptor, non-hermetic

• Primary Device ID: 46975124930071
• NIH Device Record Key: 21bd448c-1886-4450-92df-f11cc5f23dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: VA-1F13
• Company DUNS: 601849929
• Company Name: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975124930073 [Package]; Package: carton [1500 Units]; In Commercial Distribution
GS1	46975124930071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222718

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

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: 2023-11-08
• Device Publish Date: 2023-10-31