| Primary Device ID | 30887529000091 |
| NIH Device Record Key | 4e8c66cd-eab5-4545-bde2-0fe3387de502 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | BT-220C |
| Catalog Number | OSD-14220-001 |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr | |
| Phone | 949-614-8745 |
| fshurjoon@bistos.co.kr |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887529000090 [Primary] |
| GS1 | 00887529000311 [Package] Contains: 00887529000090 Package: Gift Box [1 Units] In Commercial Distribution |
| GS1 | 10887529000097 [Package] Contains: 00887529000090 Package: Gift Box [1 Units] In Commercial Distribution |
| GS1 | 20887529000094 [Package] Contains: 10887529000097 Package: Carton Box [10 Units] In Commercial Distribution |
| GS1 | 30887529000091 [Package] Contains: 10887529000097 Package: Carton Box [20 Units] In Commercial Distribution |
| HGM | System, Monitoring, Perinatal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-03 |
| 00887529000373 | This Head-worn light is used for medical examination by fixing it on the head and illuminating w |
| 00887529000366 | This Head-worn light is used for medical examination by fixing it on the head and illuminating w |
| 10887529000189 | Cart for BT-400 Neonatal phototherapy |
| 10887529000134 | BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with s |
| 10887529000110 | BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spec |
| 10887529000103 | BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to pr |
| 30887529000091 | Bistos’ BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put |
| 30887529000084 | Bistos’ BT-220L is a pocket size Fetal Doppler that measures the fetal heart rate and out put |
| 10887529000066 | BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi |
| 10887529000059 | BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi |
| 30887529000046 | Bistos’ BT-200T is a pocket size Fetal Doppler that measures the fetal heart rate and out put |
| 18800012341011 | This Head-worn light is used for medical examination by fixing it on the head and illuminating w |
| 08800012341007 | This Head-worn light is used for medical examination by fixing it on the head and illuminating w |