AILE

GUDID 06928737845791

Reusable NIBP Cuff

Shenzhen Coreray Technology Co., Ltd

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• Primary Device ID: 06928737845791
• NIH Device Record Key: 8468093e-a4e1-45e3-b5a8-384979164872
• Commercial Distribution Discontinuation: 2026-09-13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AILE
• Version Model Number: CR009-R-PU-005
• Company DUNS: 544519750
• Company Name: Shenzhen Coreray 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: false
• Manufacturing Date: true
• Expiration Date: true
• 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	06928737845791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211747

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2023-09-22
• Device Publish Date: 2023-09-14

Devices Manufactured by Shenzhen Coreray Technology Co., Ltd

• 06928737845791 - AILE: 2023-09-22Reusable NIBP Cuff
• 06928737845791 - AILE: 2023-09-22 Reusable NIBP Cuff
• 06928737883533 - coreray ECG cable: 2018-11-09
• 06928737883540 - coreray EKG cable: 2018-11-09
• 06928737883557 - coreray ECG cable: 2018-11-09
• 06928737883564 - coreray ECG cable: 2018-11-09
• 06928737883526 - coreray reusable SpO2 sensor: 2018-11-08