Accurate

GUDID 69273945000500

Hunan Accurate Bio-Medical Technology Co., Ltd.

Pulse oximeter, battery-powered

• Primary Device ID: 69273945000500
• NIH Device Record Key: 0ce89a5a-7d8d-4418-842a-32386372ef6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accurate
• Version Model Number: FS10D
• Company DUNS: 421349331
• Company Name: Hunan Accurate Bio-Medical Technology 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: true
• Manufacturing Date: false
• 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	69273945000500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141105

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-06

On-Brand Devices [Accurate]

• 69273945555550: FS20A
• 69273945000500: FS10D