Identity
- Trade Name
- Spectra FDA UDI
- Generic Name
- Breast pump support kit, reusable FDA UDI
- Device Name
- Spectra Wearable's accessory, 2-piece backflow protector FDA UDI
- Model / Reference
- Spectra Wearable Accessory (backflow protector) FDA UDI
- Description
- Spectra Wearable's accessory, 2-piece backflow protector FDA UDI
Identifiers
- Catalog Number
- MM830032 FDA UDI
- Primary DI / UDI-DI
- 08809108017765 FDA UDI
- 510(k) Number
- K220926 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
No
FDA UDI
Convenience Kit
No
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
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.
- Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 21 mm — MAYMOM LLC · Class II
- Unimom — Unimom.Co · Class II
- PNSMX Resupply kits — Medela LLC · Class II
- 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
Cleared under the same submission
K220926 also covers:
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
- Spectra — Uzinmedicare Co., Ltd.
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 82676c62-1d27-425c-b449-66587dc074e4 35 fields · synced May 30, 2026