Identity
- Trade Name
- EnJoye Metal Luer lock FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- Breast Pump EnJoye with Metal Luer Lock FDA UDI
- Model / Reference
- 10-0055s3 FDA UDI
- Description
- Breast Pump EnJoye with Metal Luer Lock FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00865278000417 FDA UDI
- 510(k) Number
- K081932 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
EnJoye Metal Luer lock by Hygeia Ii Medical Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081932 also covers:
- EnDeare Breaast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnDeare Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Cordless Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Cordless Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Cordless Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Cordless Metal Luer Lock — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Freedom Breast Pump — HYGEIA II MEDICAL GROUP, INC.
- EnJoye Freedom Breast Pump — HYGEIA II MEDICAL GROUP, INC.
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 c37b2b72-7e4f-420b-8dd5-863ff244cc9d 34 fields · synced Jun 8, 2026