bili-hut™ fully disposable nest & mattress (5-Pack)

GUDID 00810101280504

LITTLE SPARROWS TECHNOLOGIES LLC

Overhead infant phototherapy unit
Primary Device ID00810101280504
NIH Device Record Key5a6ada0c-efc2-468c-9b2b-316a19e503d8
Commercial Distribution StatusIn Commercial Distribution
Brand Namebili-hut™ fully disposable nest & mattress (5-Pack)
Version Model Number0133AFD5
Company DUNS078764736
Company NameLITTLE SPARROWS TECHNOLOGIES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810101280504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBIUnit, Neonatal Phototherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-03
Device Publish Date2024-03-26

Devices Manufactured by LITTLE SPARROWS TECHNOLOGIES LLC

00810101280504 - bili-hut™ fully disposable nest & mattress (5-Pack)2024-04-03
00810101280504 - bili-hut™ fully disposable nest & mattress (5-Pack)2024-04-03
00810101280542 - bili-hut™ fully disposable convenience kit (5-Pack) 2024-04-03
00810101280023 - bili-hut™2022-03-18
00810101280047 - bili-hut™2022-03-18
00810101280054 - bili-hut™2022-03-18
00810101280405 - bili-hut™2022-03-18
00810101280412 - bili-hut™ fully disposable nest & mattress2022-03-18
00810101280436 - bili-hut™ disposable nest liner & mattress2022-03-18

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