SpO2 Unit(Nellcor)

Basic Information

• Brand Name: SpO2 Unit(Nellcor)
• Primary DI: 04942962616263
• Version / Model: 61626
• Catalog Number: 61626
• 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: 36d658aa-f6a8-4252-bc4c-784ee7e06ce3

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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
FMT	Warmer, Infant Radiant	General Hospital	880.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36742	Open infant incubator	A mains electricity (AC-powered) unit that functions similar to a standard infant incubator but is open, having low side walls and no top enclosure, giving instant access to the infant. Such infants are not premature but suffer from disorders where intensive care is required. This device is equipped with overhead heating lamp(s), oxygen therapy flowmeter, gas mixer, suction system, facilities for infusion pumps, and other equipment. The main difference between this device and a closed infant incubator is the inability of this device to regulate the oxygen environment surrounding the occupant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04942962616263	GS1

Customer Contacts

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