N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00887529000137
• Version / Model: BT-500
• Catalog Number: MKT-500-1509
• 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: e15e2aa9-1f21-49cc-b168-d24482b5f0d4

Device Description

BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.

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
FMZ	Incubator, Neonatal	General Hospital	880.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36025	Conventional infant incubator	A mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10887529000134	GS1	Carton Box	1	In Commercial Distribution
Primary	00887529000137	GS1
Package	00887529000212	GS1	Carton Box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132543	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius