FDA UDI
In Commercial Distribution
🇺🇸 United States
Lansinoh
DI: 00044677533515
·
Model: Smartpump 3.0 Double Electric Breast Pump
·
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lansinoh
- Primary DI
- 00044677533515
- Version / Model
- Smartpump 3.0 Double Electric Breast Pump
- Catalog Number
- 53351
- Company Name
- LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
- Labeler DUNS
- 502960539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 1
- Public Version Date
- 2023-07-11
- Public Version Status
- New
- Public Device Record Key
- 8888972f-2220-4c62-b311-c1f4a34431c4
Device Description
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|---|---|
| Package | 60044677533517 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00044677533515 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222726 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 95 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 95 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal