ATOM Medical USA, Disposable Probe

Basic Information

• Brand Name: ATOM Medical USA, Disposable Probe
• Primary DI: 00860007476310
• Version / Model: NF-023T
• Company Name: Atom Medical Usa, LLC
• Labeler DUNS: 070066016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-02-08
• Public Version: 1
• Public Version Date: 2022-02-16
• Public Version Status: New
• Public Device Record Key: 18dfa9c0-0b03-4687-a225-7de4ec303cc9

Device Description

ATOM Disposable Skin Temp Probe BOX/20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMZ	Incubator, Neonatal	General Hospital	880.5400	2
FMT	Warmer, Infant Radiant	General Hospital	880.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35254	General-purpose patient temperature probe, single-use	A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007476310	GS1
Unit of Use	00860007476303	GS1

Premarket Submissions

Submission Number	Supplement Number
K071977	000