Accurate®

GUDID 69273945000128

Hunan Accurate Bio-Medical Technology Co., Ltd.

Pulse oximeter, battery-powered

• Primary Device ID: 69273945000128
• NIH Device Record Key: 235db9ba-e2e9-4b24-a0a7-d985862328e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accurate®
• Version Model Number: FS10C
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	69273945000128 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-17
• Device Publish Date: 2018-07-17

On-Brand Devices [Accurate®]

• 06927394555555: FS20A
• 06927394544443: FS10A
• 06927394533331: HS10A
• 06927394500081: FS20E
• 06927394500074: FS10E
• 06927394500067: FS20D
• 06927394500050: FS10D
• 06927394500036: FS10B
• 06927394500029: FS20B
• 06927394500012: FS10C
• 06927394500005: FS20C
• 69273945000814: FS20E
• 69273945000746: FS10E
• 69273945000128: FS10C
• 69273945000050: FS20C
• 06927394533348: HS10A
• 06927394511179: FS10F
• 06927394511162: FS20F
• 06927394511148: FS20P
• 06927394511131: FS10I
• 06927394511124: FS20I
• 06927394511117: FS20K
• 06927394511100: FS10K
• 06927394501606: FS20M
• 06927394501590: FS10M
• 06927394501583: WS20A