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 the 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 flange, tubing, connectors, and milk collection cup. This is a reusable device. FDA UDI
- Model / Reference
- Spectra accessory (Cara Cup Backflow Cap) FDA UDI
- Description
- A collection of non-sterile items intended to be used in conjunction with the 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 flange, tubing, connectors, and milk collection cup. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809108014214 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.
- 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
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 be4b7b65-62bd-48d2-8708-c539d46a8e04 34 fields · synced Jun 8, 2026