FDA UDI
In Commercial Distribution
🇺🇸 United States
Spectra
DI: 08809108016485
·
Model: Spectra 9plus_cara cup
·
UZINMEDICARE CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Spectra
- Primary DI
- 08809108016485
- Version / Model
- Spectra 9plus_cara cup
- Company Name
- UZINMEDICARE CO.,LTD
- Labeler DUNS
- 688451947
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-19
- Public Version
- 1
- Public Version Date
- 2024-02-27
- Public Version Status
- New
- Public Device Record Key
- 9b06d588-7d9d-487a-a509-e7336e136d11
Device Description
This is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with necessary connecting parts including Cara Cups, and instruction for use. So the user can use the device right after receiving them.
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
- 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 | 08809108016485 | GS1 | ||||
| Package | 28809108016489 | GS1 | Carton box | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162415 | 000 |
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
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 95 Percent (%) Relative Humidity