FDA UDI
In Commercial Distribution
🇺🇸 United States
Lansinoh Manual Breast Pump
DI: 20044677505202
·
Model: MBP 1.0
·
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Lansinoh Manual Breast Pump
- Primary DI
- 20044677505202
- Version / Model
- MBP 1.0
- Catalog Number
- 50520
- Company Name
- LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
- Labeler DUNS
- 502960539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2017-12-05
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 5102df6a-b683-4313-921f-83bddb1e186b
Device Description
The Non-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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 60044677505200 | GS1 | Outer Carton | 6 | In Commercial Distribution | |
| Primary | 20044677505202 | GS1 | ||||
| Unit of Use | 00044677505208 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 95 Percent (%) Relative Humidity