Olympic Bili-Bassinet

FDA UDI

Class II (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name: Olympic Bili-Bassinet FDA UDI
Generic Name: Blanket/pad infant phototherapy unit FDA UDI
Device Name: Disposable Mattress Covers, one-piece mattress for Bili-Bassinet FDA UDI
Model / Reference: Mattress Covers FDA UDI
Description: Disposable Mattress Covers, one-piece mattress for Bili-Bassinet FDA UDI

Identifiers

Catalog Number: 58106 FDA UDI
Primary DI / UDI-DI: 00382830003971 FDA UDI
FDA Product Code: LBI FDA UDI
GMDN Term: Blanket/pad infant phototherapy unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 24.00 Inch FDA UDI
Length — 33.50 Inch FDA UDI

Category: Blanket/pad infant phototherapy unit

Olympic Bili-Bassinet by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Blanket/pad infant phototherapy unit.

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CloudCover Plus — NEOLIGHT LLC · Class II
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Pad Cover(L) For BILI-THERAPY Pad Type(50 pcs/box) — Atom Medical Corp · Class II
Pad(L) For BILI-THERAPY Pad Type — Atom Medical Corp · Class II
BiliCocoon™ Service Kit — NEOMEDLIGHT · Class II
AirLife™ — AirLife Finland Oy · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Natus Medical Incorporated

Sources (1)

FDA UDI d71cbb4a-6ff1-45af-9515-52d809686068 36 fields · synced Jun 1, 2026