Identity
- Trade Name
- AVANOS* FDA UDI
- Generic Name
- Elastomeric infusion pump system FDA UDI
- Device Name
- ON-Q* Pain Relief System, SELECT-A-FLOW*, Bolus, NRFit™ Connector, 400 ml, 2-14 ml/hr + 3 ml bolus/20 min FDA UDI
- Model / Reference
- 47057 FDA UDI
- Description
- ON-Q* Pain Relief System, SELECT-A-FLOW*, Bolus, NRFit™ Connector, 400 ml, 2-14 ml/hr + 3 ml bolus/20 min FDA UDI
Identifiers
- Catalog Number
- CB006C-N FDA UDI
- Primary DI / UDI-DI
- 00193494470579 FDA UDI
- 510(k) Number
- K181360 FDA UDI
- FDA Product Code
- MEB FDA UDI
- GMDN Term
- Elastomeric infusion pump system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
No
FDA UDI
Category: Elastomeric infusion pump system
Avanos* by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elastomeric infusion pump system.
- SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h — Epic International (Thailand) Co., Ltd. · Class IIa
- Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
- SMARTeZ RS-General Infusion 250-500-30m with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- Neofuser Twin — S&S Med Co.,Ltd. · Class IIb
- SMARTeZ RS-PainBloc-Fixed Flow Rate 120-5-24h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ Pump 500-40-12.5h — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ RS-PainBloc-Fixed Flow Rate 80-5-16h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ RS-General Infusion 100-8-12.5h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
Cleared under the same submission
K181360 also covers:
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- AVANOS* — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, 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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI 442e1e88-5da7-4ac6-8d65-50c0cb919329 36 fields · synced Jun 9, 2026