Identity
- Trade Name
- ON-Q* Pain Relief System FDA UDI
- Generic Name
- Elastomeric infusion pump kit FDA UDI
- Device Name
- ON-Q* Pump with ONDEMAND* FDA UDI
- Model / Reference
- 13646 FDA UDI
- Description
- ON-Q* Pump with ONDEMAND* FDA UDI
Identifiers
- Catalog Number
- PS12504 FDA UDI
- Primary DI / UDI-DI
- 00193494136468 FDA UDI
- 510(k) Number
- K063530 FDA UDI
- FDA Product Code
- MEB FDA UDI
- GMDN Term
- Elastomeric infusion pump kit 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 270 Milliliter FDA UDI
Category: Elastomeric infusion pump kit
ON-Q* Pain Relief System by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Elastomeric infusion pump kit.
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Cleared under the same submission
K063530 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 71abfdc9-34ac-447f-8dab-f7fd05af3a08 37 fields · synced Jun 9, 2026