FDA UDI
In Commercial Distribution
🇺🇸 United States
The Pump by Babyation
DI: 00850004964002
·
Model: BP1
·
Babyation Inc.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- The Pump by Babyation
- Primary DI
- 00850004964002
- Version / Model
- BP1
- Company Name
- Babyation Inc.
- Labeler DUNS
- 079845487
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-25
- Public Version
- 2
- Public Version Date
- 2022-10-03
- Public Version Status
- Update
- Public Device Record Key
- 4fea2acb-28de-4d58-903e-26edae5b56e1
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
- 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 | 00850004964002 | GS1 | ||||
| Package | 00850004964019 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00850004964026 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00850004964040 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00850004964057 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 8447447867
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173699 | 000 |