FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00887529000083
·
Model: BT-220L
·
Bistos Co., Ltd.
Product Codes
1
GMDN Terms
2
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00887529000083
- Version / Model
- BT-220L
- Catalog Number
- OSD-14220-001
- 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
- 5
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 898c7eff-7b17-4bb1-a969-4f1431f97c5e
Device Description
Bistos’ BT-220L is a pocket size Fetal Doppler that measures the fetal heart rate and out put the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being.
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 |
|---|---|---|---|---|
| HGM | System, Monitoring, Perinatal | Obstetrics/Gynecology | 884.2740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41917 | Foetal Doppler system probe | A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device. | No | Active |
| 34040 | Foetal Doppler system | A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30887529000084 | GS1 | Carton Box | 20 | In Commercial Distribution | |
| Package | 10887529000080 | GS1 | Gift Box | 1 | In Commercial Distribution | |
| Primary | 00887529000083 | GS1 | ||||
| Package | 20887529000087 | GS1 | Carton Box | 10 | In Commercial Distribution | |
| Package | 00887529000328 | GS1 | Gift Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 949-614-8745
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142799 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 85 Percent (%) Relative Humidity