Identity
- Trade Name
- Spectra FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- This is 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 neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them. FDA UDI
- Model / Reference
- Spectra S2 plus FDA UDI
- Description
- This is 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 neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them. FDA UDI
Identifiers
- Catalog Number
- MM011305 FDA UDI
- Primary DI / UDI-DI
- 08809108016430 FDA UDI
- 510(k) Number
- K150476 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breast pump, electric
Spectra by Uzinmedicare Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast pump, electric.
- AMEDA® — CIMILRE CO ., LTD · Class II
- Nurture Bra — IMALAC, INC. · Class I
- Nurture Bra — IMALAC, INC. · Class I
- Nurture Bra — IMALAC, INC. · Class I
- 96ct Milk Bag Package — WILLOW INNOVATIONS, INC. · Class II
- Little Martin's Drawer — EBZNS HOLDINGS LLC · Class II
- LVB — Huizhou LVB Maternal & Infant Supplies Co., Ltd. · Class II
- Symmetrical Health, LLC — CIMILRE CO ., LTD · Class II
Cleared under the same submission
K150476 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Uzinmedicare Co., Ltd.
Sources (1)
- FDA UDI 42b93959-db5c-4ab9-bb02-7ba91269f626 37 fields · synced May 30, 2026