FDA.reportPublic FDA data

bili-ruler

Primary DI
00810101280498
Brand
bili-ruler
Company
LITTLE SPARROWS TECHNOLOGIES LLC
Model
0
Catalog number
0203A
Device description
Jaundice Screening Device
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HITTester, Color Vision

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HITTester, Color VisionOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810101280498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810101280498008101012804988101012804980810101280498

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous bilirubinometerA noninvasive, battery-powered, hand-held, portable instrument intended to measure transcutaneous bilirubin (TcB) levels, in order to predict total serum bilirubin (TSB) levels in a neonate. It directs a light beam into the newborn’s skin, usually on the forehead, sternum or ear, and measures the intensity of multiple wavelengths (typically 2 or more) that are reflected from the newborns subcutaneous tissue. These optical signals are processed (typically by a photocell and microprocessor) to give a TcB and/or TSB value. It is used mainly for screening hyperbilirubinemia.

Regulatory Flags#

DUNS number
078764736
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810101280559garden friendslarge butterfly0503LB2025-12-01
00810101280566garden friendssmall butterfly0504SB2025-12-01
00810101280573garden friendsinch worm0505IW2025-12-01
00810101280580garden friendscaterpillar0506CT2025-12-01
00810101280603bili-hut™ disposable nest mattress cover0182NMC2025-11-25
00810101280504bili-hut™ fully disposable nest & mattress (5-Pack)0133AFD52024-03-26
00810101280542bili-hut™ fully disposable convenience kit (5-Pack) 0133FDK52024-03-26
00810101280023bili-hut™0130A2022-03-10
00810101280047bili-hut™0130A2022-03-10
00810101280054bili-hut™0130A2022-03-10
00810101280405bili-hut™0130A2022-03-10
00810101280412bili-hut™ fully disposable nest & mattress0133AFD32022-03-10
00810101280436bili-hut™ disposable nest liner & mattress0133ADL52022-03-10
00810101280443bili-hut™ nest frame with disposable nest liner & mattress0103BDL2022-03-10
00810101280450bili-hut™ perch0108A2022-03-10
00850019925036bili-hut™0130A2022-03-10
00850019925357bili-hut™0130A2022-03-10
00850019925364bili-hut™0130A2022-03-10
00850019925371bili-hut™0130A2022-03-10
00850019925388bili-hut™0130A2022-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860010709788Virtual Eye SoftwareVirtual Vision HealthHIT2024-11-27
00860010709757Virtual Eye SoftwareVirtual Vision HealthHIT2024-08-20
00860010709740Virtual Eye SoftwareVirtual Vision HealthHIT2024-05-07
00860010709733Virtual Eye SoftwareVirtual Vision HealthHIT2024-02-27
00860001720433Virtual FieldVirtual Field, Inc.HIT2023-11-08
G506NC010NeuroColorAMA Optics, Inc.HIT2023-09-30
04582275270068NAKONAN MEDICAL USA, INC.HIT2023-06-15
00860001720402Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720426Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HIT2023-01-23
04049584014795C-QuantOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHIT2022-12-07
06971821401038Computerized vision testerNingbo Ming Sing Optical R & D Co., Ltd.HIT2020-08-20
06971821401021COMPUTERIZED VISION TESTERNingbo Ming Sing Optical R & D Co., Ltd.HIT2019-12-02