FDA UDI
In Commercial Distribution
🇺🇸 United States
Duo Double Electric Breast Pump
DI: 00887529000465
·
Model: AAA0021
·
Bistos Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Duo Double Electric Breast Pump
- Primary DI
- 00887529000465
- Version / Model
- AAA0021
- Company Name
- Bistos Co., Ltd.
- Labeler DUNS
- 689908411
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-28
- Public Version
- 1
- Public Version Date
- 2021-11-05
- Public Version Status
- New
- Public Device Record Key
- 01769e84-842e-4be0-a4d8-2efec9246419
Device Description
The Duo Double Electric Breast Pump is a single user, double electric breast pump that includes customizable massage and expression modes and is capable of single and double pumping.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| HGX | Pump, Breast, Powered | Obstetrics/Gynecology | 884.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38478 | Breast pump, electric | A mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887529000465 | GS1 | ||||
| Package | 00887529000472 | GS1 | Gift Box | 1 | In Commercial Distribution | |
| Package | 10887529000479 | GS1 | Carton Box | 6 | In Commercial Distribution | |
| Package | 00887529000489 | GS1 | Gift Box(with Bag) | 1 | In Commercial Distribution | |
| Package | 10887529000486 | GS1 | Carton Box(with Bag) | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 844-272-8390
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160274 | 000 |