FDA UDI
In Commercial Distribution
🇺🇸 United States
Breast Pump
DI: 06972562618259
·
Model: BLA-8017
·
NINGBO HUIYOO BABY PRODUCTS CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Breast Pump
- Primary DI
- 06972562618259
- Version / Model
- BLA-8017
- Company Name
- NINGBO HUIYOO BABY PRODUCTS CO.,LTD
- Labeler DUNS
- 554457373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-28
- Public Version
- 1
- Public Version Date
- 2020-03-09
- Public Version Status
- New
- Public Device Record Key
- 30e1c11e-f5e1-4908-a687-53a4f29eb980
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HGY | Pump, Breast, Non-Powered | Obstetrics/Gynecology | 884.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38477 | Breast pump, manual | A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06972562618259 | GS1 |