Duns Number:689908411
Device Description: Hi bebe plus BT-100 is a single user, home use electric breast pump that include massage a Hi bebe plus BT-100 is a single user, home use electric breast pump that include massage and express mode and is capable of single and double pumping.
Catalog Number
MKT-100-1509
Brand Name
Hi bebe plus
Version/Model Number
BT-100
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160274,K160274,K160274
Product Code
HGX
Product Code Name
Pump, Breast, Powered
Public Device Record Key
6164a360-e790-4d97-ab2f-e95772981bde
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 08, 2016
Package DI Number
10887529000165
Quantity per Package
10
Contains DI Package
887529000168
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 |