Identity
- Trade Name
- Ameda, Inc FDA UDI
- Generic Name
- Breast pump support kit, single-use FDA UDI
- Device Name
- Tubing Adapter FDA UDI
- Model / Reference
- 10004 FDA UDI
- Description
- Tubing Adapter FDA UDI
Identifiers
- Catalog Number
- 10004 FDA UDI
- Primary DI / UDI-DI
- 00810725023082 FDA UDI
- 510(k) Number
- K011519 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump support kit, single-use 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breast pump support kit, single-use
Ameda, Inc by Ameda, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast pump support kit, single-use.
- Symphony & Lactina Breastmilk Initiation Kit- Sterile — Medela LLC · Class II
- Syphony Breat pump kit- Sterile — Medela LLC · Class II
- ViveCare — VIVE HEALTH LLC · Class II
- ViveCare — VIVE HEALTH LLC · Class II
- Symphony Single Kit-Sterile — Medela LLC · Class II
- Symphony & Lactina Breastpump kit- Sterile — Medela LLC · Class II
- Symphony Breastmilk Initiation Kit-Sterile — Medela LLC · Class II
- ViveCare — VIVE HEALTH LLC · Class II
Cleared under the same submission
K011519 also covers:
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
- Ameda, Inc.
Sources (1)
- FDA UDI d9340328-dfe4-4219-8da0-7309ea9ef3a8 37 fields · synced May 31, 2026