Identity
- Trade Name
- Hospital Kit DeTach 21 mm FDA UDI
- Generic Name
- Breast pump support kit, single-use FDA UDI
- Device Name
- The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Hospital Kit can be used both as a single pumpset and as a double pumpset and is intended for single users only. FDA UDI
- Model / Reference
- 63.00.476 FDA UDI
- Description
- The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Hospital Kit can be used both as a single pumpset and as a double pumpset and is intended for single users only. FDA UDI
Identifiers
- Catalog Number
- 63.00.476 FDA UDI
- Primary DI / UDI-DI
- 07640108055507 FDA UDI
- 510(k) Number
- K172067 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breast pump support kit, single-use
Hospital Kit DeTach 21 mm by Ardo medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Breast pump support kit, single-use.
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Cleared under the same submission
K172067 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 |
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Manufacturer
- Manufacturer
- Ardo medical AG
Sources (1)
- FDA UDI aa3e76ea-a044-43e7-843c-2520292a5ec3 36 fields · synced May 30, 2026