Identity
- Trade Name
- Spectra FDA UDI
- Generic Name
- Breast pump support kit, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Spectra accessory (28mm Care Cup) FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- MM012238 FDA UDI
- Primary DI / UDI-DI
- 08809108013767 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 28 Millimeter 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.
- Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 21 mm — MAYMOM LLC · Class II
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- Hands-free Breast shields, 24mm — Medela LLC · Class II
- Neotech Bridge® — Neotech Products LLC · Class I
- 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 986c125b-5adc-4efd-aea6-2cb17e3af7ce 36 fields · synced Jun 6, 2026