Duns Number:689908411
Device Description: BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body 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.
Catalog Number
MKT-500-1509
Brand Name
N/A
Version/Model Number
BT-500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132543,K132543,K132543
Product Code
FMZ
Product Code Name
Incubator, Neonatal
Public Device Record Key
e15e2aa9-1f21-49cc-b168-d24482b5f0d4
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 03, 2016
Package DI Number
10887529000134
Quantity per Package
1
Contains DI Package
00887529000137
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |