Identity
- Trade Name
- Spectra FDA UDI
- Generic Name
- Breast pump support kit, reusable FDA UDI
- Device Name
- A collection of non-sterile 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. This is a reusable device. FDA UDI
- Model / Reference
- Milk storage bottles FDA UDI
- Description
- A collection of non-sterile 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. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809108014832 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump support kit, reusable 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breast pump support kit, reusable
Spectra by Uzinmedicare Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast pump support kit, reusable.
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- Freemie — DAO HEALTH · Class II
- Symphony Double Pumping Kit — Medela LLC · Class II
- Freemie — DAO HEALTH · Class II
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 |
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Manufacturer
- Manufacturer
- Uzinmedicare Co., Ltd.
Sources (1)
- FDA UDI ebf371cf-07bf-4575-b73e-d7c4a7ea503e 34 fields · synced May 30, 2026