MINDRAY

GUDID 16972620112160

BQ PLUS MEDICAL CO., LTD.

Electronic gravity infusion controller administration set

• Primary Device ID: 16972620112160
• NIH Device Record Key: 853ce125-1112-4381-8493-cee21eb17494
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINDRAY
• Version Model Number: S-IS-002DL
• Company DUNS: 544463583
• Company Name: BQ PLUS MEDICAL CO., LTD.
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16972620112160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210381

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2024-01-08
• Device Publish Date: 2023-12-31

On-Brand Devices [MINDRAY]

• 16972620118018: S-BS-002D
• 16972620114836: S-ES-000
• 16972620113013: S-TS-000D
• 16972620112306: S-LS-002D
• 16972620112283: S-LS-000D
• 16972620112269: S-PS-102D
• 16972620112245: S-PS-003D
• 16972620112221: S-PS-002D
• 16972620112207: S-IS-100D
• 16972620112184: S-IS-003D
• 16972620112160: S-IS-002DL
• 16972620112146: S-IS-002D
• 16972620112122: S-IS-000D
• 06972620118004: S-BS-002D
• 06972620114822: S-ES-000
• 06972620113009: S-TS-000D
• 06972620112293: S-LS-002D
• 06972620112279: S-LS-000D
• 06972620112255: S-PS-102D
• 06972620112231: S-PS-003D
• 06972620112217: S-PS-002D
• 06972620112194: S-IS-100D
• 06972620112170: S-IS-003D
• 06972620112156: S-IS-002DL
• 06972620112132: S-IS-002D
• 06972620112118: S-IS-000D