BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Olympic Bili-Bassinet

DI: 00382830003971 · Model: Mattress Covers · NATUS MEDICAL INCORPORATED

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

48

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Basic Information

Brand Name: Olympic Bili-Bassinet
Primary DI: 00382830003971
Version / Model: Mattress Covers
Catalog Number: 58106
Company Name: NATUS MEDICAL INCORPORATED
Labeler DUNS: 962519208
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 48
Record Status: Published
Publish Date: 2017-05-19
Public Version: 4
Public Version Date: 2026-01-09
Public Version Status: Update
Public Device Record Key: d71cbb4a-6ff1-45af-9515-52d809686068
Distribution End Date: 2026-01-07

Device Description

Disposable Mattress Covers, one-piece mattress for Bili-Bassinet

Device Characteristics

Single Use: Yes
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: No
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
LBI	Unit, Neonatal Phototherapy	General Hospital	880.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33791	Blanket/pad infant phototherapy unit	A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a light source that connects to a blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. It is intended for use in the home and a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382830003971	GS1
Unit of Use	00382830054591	GS1

Customer Contacts

Phone: 1-800-303-0306
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	24.00	Inch
Length	33.50	Inch