Alcedo

GUDID 10856471007171

AE171 Digital Thermometer is a forehead and ear temperature measurement device

NATURE MAJOR INC

Infrared patient thermometer, skin

• Primary Device ID: 10856471007171
• NIH Device Record Key: 0269e6de-2008-4609-935b-ab0e9b1cb077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alcedo
• Version Model Number: AE171
• Company DUNS: 114908257
• Company Name: NATURE MAJOR INC
• 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: 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	00856471007174 [Primary]
GS1	10856471007171 [Package]; Contains: 00856471007174; Package: Master carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172795

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2019-10-30
• Device Publish Date: 2019-10-22

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• 10856471007089: Upper Arm Blood Pressure Monitor
• 10856471007171: AE171 Digital Thermometer is a forehead and ear temperature measurement device
• 10856471007201: Fingertip Pulse Oximeter
• 10856471007218: Phlebotomy Sharps Container 1 quart
• 20856471007239: Alcedo TENS Unit
• 10856471007324: Upper Arm Blood Pressure Monitor
• 10856471007317: Upper Arm Blood Pressure Monitor
• 10856471007300: Phlebotomy Sharps Container 2 Quart
• 10856471007287: Phlebotomy Sharps Container 2 Gallon
• 10856471007263: Phlebotomy Sharps Container 2 Gallon