FDA UDI
In Commercial Distribution
🇺🇸 United States
Spectra
DI: 08809108013767
·
Model: Spectra accessory (28mm Care Cup)
·
UZINMEDICARE CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Spectra
- Primary DI
- 08809108013767
- Version / Model
- Spectra accessory (28mm Care Cup)
- Catalog Number
- MM012238
- Company Name
- UZINMEDICARE CO.,LTD
- Labeler DUNS
- 688451947
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-09
- Public Version
- 2
- Public Version Date
- 2024-09-16
- Public Version Status
- Update
- Public Device Record Key
- 986c125b-5adc-4efd-aea6-2cb17e3af7ce
Device Description
This is placed in the bra, allowing moms to express breastmilk hands free. It is connected to backdraft prevention unit (cap), pressure adjustment unit (silicon head) and bottle when used.
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
- No
- 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 |
|---|---|---|---|---|
| 61734 | Breast pump support kit, reusable | A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28809108013761 | GS1 | Design box | 8 | In Commercial Distribution | |
| Primary | 08809108013767 | GS1 |
Customer Contacts
- Phone
- +821053081195
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 28 | Millimeter |