R-RUI

GUDID 16944290665215

Beijing Rongrui-Century Scie.&Tech. Co,. Ltd.

Pulse oximeter probe, single-use

• Primary Device ID: 16944290665215
• NIH Device Record Key: c7224c82-31c4-48ce-a04c-e1223cff7abe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-RUI
• Version Model Number: RSA002DN
• Company DUNS: 545347903
• Company Name: Beijing Rongrui-Century Scie.&Tech. Co,. Ltd.
• Device Count: 30
• 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: true
• 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	06944290660541 [Unit of Use]
GS1	16944290665215 [Primary]
GS1	26944290669142 [Package]; Package: Box [180 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103685

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-11
• Device Publish Date: 2022-11-12

On-Brand Devices [R-RUI]

• 16944290664959: RSA001DA
• 16944290665215: RSA002DN
• 06944290663399: RST063CA
• 06944290662712: RSJ091DI
• 06944290660916: RSJ002DA
• 06944290653932: RCT006
• 06944290650580: RCT018