BRAUN

GUDID 16921745201198

The Braun Pulse oximeter (BPX801) is a non-sterile, reusable device intended for spot checking or intermittent determination of oxygen saturation in arterial blood, as well as the associated pulse rate by using the tip of the finger as the measurement site. The device is intended for adults 21 year of age or older, in a home-use environment (such as a home setting or places of business).

Xuzhou Yongkang Electronic Science Technology Co., Ltd

Pulse oximeter

• Primary Device ID: 16921745201198
• NIH Device Record Key: ec3afc26-c248-4509-8277-eae801b71d0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRAUN
• Version Model Number: BPX801US
• Company DUNS: 542753796
• Company Name: Xuzhou Yongkang Electronic Science Technology Co., Ltd
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06921745201191 [Primary]
GS1	16921745201198 [Package]; Contains: 06921745201191; Package: [1 Units]; In Commercial Distribution
GS1	26921745201195 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• DQA: Oximeter

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: 2025-06-25
• Device Publish Date: 2025-06-17

Devices Manufactured by Xuzhou Yongkang Electronic Science Technology Co., Ltd

• 06921745201061 - Yonker: 2025-06-25 The fingertip pulse oximeter can be used to measure human haemoglobin saturation and pulse rate through finger , it can be used
• 16921745201198 - BRAUN: 2025-06-25The Braun Pulse oximeter (BPX801) is a non-sterile, reusable device intended for spot checking or intermittent determination of oxygen saturation in arterial blood, as well as the associated pulse rate by using the tip of the finger as the measurement site. The device is intended for adults 21 year of age or older, in a home-use environment (such as a home setting or places of business).
• 16921745201198 - BRAUN: 2025-06-25 The Braun Pulse oximeter (BPX801) is a non-sterile, reusable device intended for spot checking or intermittent determination of
• 06921745205014 - Yonker: 2025-06-25
• 06921745209029 - UV Radiation Treatment System: 2022-08-11
• 06921745200156 - yonker: 2019-11-08
• 06921745200026 - yonker: 2019-01-11 Fingertip Pulse Oximeter
• 06921745200033 - yonker: 2019-01-11 Fingertip Pulse Oximeter
• 06921745200163 - yonker: 2019-01-11 Wrist type Blood Pressure Monitor