Atom Infant Incubator 100 AC120V w/o O2 Controller Unit

Basic Information

• Brand Name: Atom Infant Incubator 100 AC120V w/o O2 Controller Unit
• Primary DI: 04942962616027
• Version / Model: 61602
• Catalog Number: 61602
• Company Name: ATOM MEDICAL CORPORATION
• Labeler DUNS: 690632047
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2019-01-29
• Public Version Status: Update
• Public Device Record Key: d3781a8a-5522-4e40-84a4-7ca937a9ce78

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
36025	Conventional infant incubator	A mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04942962616027	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Depth	68	Centimeter
Width	119	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius