ATOM Medical USA, Disposable Probe

GUDID 00860007476310

ATOM Disposable Skin Temp Probe BOX/20

Atom Medical Usa, LLC

General-purpose patient temperature probe, single-use

• Primary Device ID: 00860007476310
• NIH Device Record Key: 18dfa9c0-0b03-4687-a225-7de4ec303cc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOM Medical USA, Disposable Probe
• Version Model Number: NF-023T
• Company DUNS: 070066016
• Company Name: Atom Medical Usa, LLC
• Device Count: 20
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007476303 [Unit of Use]
GS1	00860007476310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071977

FDA Product Code

• FMZ: Incubator, Neonatal

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: 2022-02-16
• Device Publish Date: 2022-02-08