ANNE Limb Sensor Kit

GUDID 00850064210088

ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.

Sibel Health Inc.

Pulse oximeter

• Primary Device ID: 00850064210088
• NIH Device Record Key: 1c7d214c-67d0-4222-b533-5d9ca40e437f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANNE Limb Sensor Kit
• Version Model Number: 900-00003
• Company DUNS: 093772547
• Company Name: Sibel Health Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00850064210088 [Primary]

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: 2025-04-03
• Device Publish Date: 2025-03-26

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