| Primary Device ID | 10887529000165 |
| NIH Device Record Key | 6164a360-e790-4d97-ab2f-e95772981bde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hi bebe plus |
| Version Model Number | BT-100 |
| Catalog Number | MKT-100-1509 |
| Company DUNS | 689908411 |
| Company Name | Bistos Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887529000168 [Primary] |
| GS1 | 10887529000165 [Package] Contains: 887529000168 Package: Carton Box [10 Units] In Commercial Distribution |
| GS1 | 887529000168 [Package] Contains: 00887529000168 Package: Gift Box [1 Units] In Commercial Distribution |
| HGX | Pump, Breast, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-08 |
| 00887529000465 - Duo Double Electric Breast Pump | 2021-11-05 The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and express |
| 18800012345019 - BiliTouchTM | 2021-06-17 This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, |
| 18800012315029 - Hi bebe super | 2021-06-16 This electrical breast pump is an electrically powered, software-controlled breast pump intended to express and collect milk fro |
| 18800012315036 - Hi bebe super | 2021-06-16 This electrical breast pump is an electrically powered, software-controlled breast pump intended to express and collect milk fro |
| 18800012345002 - Infant Phototherapy Equipment | 2021-06-16 This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, |
| 08800012341007 - N/A | 2021-06-15 This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injur |
| 18800012341011 - N/A | 2021-06-15 This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injur |
| 00887529000366 - N/A | 2019-02-07 This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injur |