Identity
- Trade Name
- Evolve Breast Pump FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- Evolve Breast Pump, pump & Power Supply FDA UDI
- Model / Reference
- 10-0167 FDA UDI
- Description
- Evolve Breast Pump, pump & Power Supply FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001425284 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breast pump, electric
Evolve Breast Pump by Hygeia Ii Medical Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hygeia Ii Medical Group, Inc.
Sources (1)
- FDA UDI 0a086a20-826b-4829-ae12-20472ec2c1e8 33 fields · synced May 31, 2026