Andesfit

GUDID 00146191200604

Wireless Pules Oximeter

ANDESFIT LIMITED

Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 00146191200604
• NIH Device Record Key: c24c3ebd-aac6-4cd3-81d6-aa1ccaeac255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andesfit
• Version Model Number: ADF-B06
• Company DUNS: 664101036
• Company Name: ANDESFIT LIMITED
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00146191200604 [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: 2019-05-17
• Device Publish Date: 2019-05-09

On-Brand Devices [Andesfit]

• 00146191200604: Wireless Pules Oximeter
• 00146191210221: Wireless Wrist Type Blood Pressure Monitor
• 00146191201908: Wireless Arm Type Blood Pressure monitor
• 00146191010005: Wireless Spirometer
• 00146191203803: Wireless Non-Contact Infrared Body/Surface Thermometer
• 04897100310254: Upper Arm Electronic Blood Pressure Monitor