N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00887529000113
• Version / Model: BT-400
• Catalog Number: MKT-400-1510
• Company Name: Bistos Co., Ltd.
• Labeler DUNS: 689908411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-03
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e2fe443a-f128-4288-a79d-fa0fc734b1e6

Device Description

BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spectrum to treat Neonatal Jaundice to use in Bassinets, Incubators, Open beds or Radiant warmer and consists of Head (Light Source), Control box with LCD window, Roll Stand (optional)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
35239	Overhead infant phototherapy unit	A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10887529000110	GS1	Carton Box	1	In Commercial Distribution
Primary	00887529000113	GS1
Package	00887529000229	GS1	Carton Box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142332	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity