Identity
- Trade Name
- Holder with standard rail FDA UDI
- Generic Name
- Medical device service rail clamp FDA UDI
- Device Name
- Holder with standard rail for attachment of powered suction pump (e.g Invia Liberty or Thopaz) FDA UDI
- Model / Reference
- 079.0036 FDA UDI
- Description
- Holder with standard rail for attachment of powered suction pump (e.g Invia Liberty or Thopaz) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367016339 FDA UDI
- 510(k) Number
- K142626 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Medical device service rail clamp 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device service rail clamp
Holder with standard rail by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical device service rail clamp.
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- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Bracket — LivaNova USA, Inc. · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
- CAPIOX — Terumo Corp. · Class I
Cleared under the same submission
K142626 also covers:
- Docking Station — Medela LLC
- Invia Drain Adapter — Medela LLC
- Invia Liberty — Medela LLC
- Invia Liberty — Medela LLC
- Invia Liberty Carrying Case — Medela LLC
- Invia Liberty Tubing with quick connector — Medela LLC
- Invia Liberty Y-Connector with quick connector — Medela LLC
- Invia Liberty canister 0.3l — Medela LLC
- Invia Liberty canister 0.8l — Medela LLC
- Standard rail universal holder — 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 3c771051-7efe-4850-a31e-83b79761c7d5 35 fields · synced Jun 8, 2026