Identity
- Trade Name
- Clamp holder, plastic FDA UDI
- Generic Name
- Suction/irrigation system canister/bottle holder, single-use FDA UDI
- Device Name
- Clamp holder for Attachement of accessories to standard rail FDA UDI
- Model / Reference
- 077.0521 FDA UDI
- Description
- Clamp holder for Attachement of accessories to standard rail FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367031578 FDA UDI
- 510(k) Number
- K130123 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Suction/irrigation system canister/bottle holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Category: Suction/irrigation system canister/bottle holder, single-use
Clamp holder, plastic by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Suction/irrigation system canister/bottle holder, single-use.
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Cleared under the same submission
K130123 also covers:
- Angle piece — Medela LLC
- Angle piece — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic portable — Medela LLC
- Basic rack — Medela LLC
- Change-over valve with clampholder and tubing set — Medela LLC
- Diposable virus / odour Filter — Medela LLC
- Disposable Overflow Protection / Bacteria Odour Filter — Medela LLC
- Disposable Overflow Protection / Bacteria filter — Medela LLC
- Disposable Overflow Protection / Virus Filter — Medela LLC
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
- Medela LLC
Sources (1)
- FDA UDI cd4ec110-58b1-4af8-a5ed-87e073ee1c65 35 fields · synced Jun 6, 2026